Circular No. 6/2020/TT-BYT stipulates on the system of pharmaceutical and cosmetic statistical indicators issued by the Minister of Health

 CIRCULAR

REGULATIONS ON THE STATISTICAL INDICATORS SYSTEM FOR DRUGS AND COSMETICS

Pursuant to the Law on Statistics No. 89/2015/QH13 dated November 23, 2015;

Pursuant to the Decree No. 94/2016/NĐ-CP dated July 1, 2016 of the Government detailing and guiding the implementation of certain provisions of the Law on Statistics;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department;

The Minister of Health issues this Circular to regulate the statistical indicators system for drugs and cosmetics.

Article 1. Scope of Regulation

This Circular stipulates the list and contents of statistical indicators in the healthcare sector concerning medicines (including chemical drugs, herbal drugs, vaccines, biological products except in vitro diagnostic reagents), raw materials for medicines (including semi-finished herbal products, except herbs), and cosmetics.

Article 2. Statistical Indicators System for Drugs and Cosmetics

The statistical indicators system for drugs and cosmetics includes:

1. The list of statistical indicators for drugs and cosmetics is prescribed in Appendix I attached hereto.

2. The content of statistical indicators for drugs and cosmetics is prescribed in Appendix II attached hereto.

Article 3. Implementation Organization

1. The Drug Administration Department shall be responsible for:

a) Guide, monitor, urge, and inspect the implementation of this Circular;

b) Take the lead and coordinate with relevant units under the Ministry of Health to establish a reporting system for statistics in the field of drugs and cosmetics to serve the collection of statistical indicators listed in the unified statistical indicator list throughout the country;

c) Organize the collection, consolidation, and submission of reports to the Department of Planning and Finance for consolidation and publication of the list of statistical indicators.

2. The Department of Planning and Finance shall be responsible for:

a) Announce the list of statistical indicators for drugs and cosmetics based on the report collected and consolidated by the Drug Administration of Vietnam;

b) Collect and consolidate data of the statistical indicators assigned in the statistical indicators system for drugs and cosmetics and submit them to the Drug Administration of Vietnam for consolidation.

3. The Department of Health at provincial level is the main agency responsible for organizing the collection and consolidation of statistical information within its jurisdiction to serve the calculation of statistical indicators for drugs and cosmetics.

Article 4. Effective date

This Circular takes effect from July 1, 2020.

Article 5. Responsibilities for Implementation

The Director of the Office of the Ministry, the Inspector General, Heads of Departments, Directors of Bureaus, General Directors of General Departments under the Ministry of Health, Provincial Health Department Directors, and related agencies, organizations, and individuals are responsible for implementing this Circular. In the course of implementation, if there are any difficulties, agencies, organizations, and individuals shall promptly reflect them to the Drug Administration of Vietnam for consideration and resolution.

In the course of implementation, if there are any difficulties, agencies, organizations, and individuals shall promptly reflect them to the Drug Administration of Vietnam for consideration and resolution./.

 

 

ANNEX I

LIST OF STATISTICAL INDICATORS FOR DRUGS AND COSMETICS
(Attached to Circular No.      /2020/TT-BYT dated    month   year 2020 issued by the Minister of Health)

 

ANNEX II

CONTENT OF STATISTICAL INDICATORS FOR DRUGS AND COSMETICS
(Attached to Circular No.       /2020/TT-BYT dated   month    year 2020 issued by the Minister of Health)

01. HUMAN RESOURCES IN THE PHARMACEUTICAL SECTOR

0101. Number of pharmaceutical personnel

1. Concept, Calculation Method:

The number of pharmaceutical personnel is the total number of people trained in pharmaceuticals (including both civil servants and contractual employees) currently working in state administrative agencies, public institutions, production and business units, and other healthcare facilities (including both state-managed and private units) in a region at the time of reporting.

2. Major classification:

- Gender;

- Ethnicity (Kinh/others);

- Level (Primary/Middle/College/University/Postgraduate);

- Province/Central City.

3. Year of publication: Year.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and consolidating: The Drug Administration of Vietnam.

6. Units coordinating and providing information:

- Health Departments of provinces and centrally governed cities

- Units under the Ministry of Health;

- Health sector.

0102. Number of pharmacists with university and postgraduate degrees working in state administrative agencies and public institutions

1. Concept, Calculation Method:

The number of pharmacists with bachelor's or postgraduate degrees working in state management agencies and public institutions is the total number of pharmacists with bachelor's or postgraduate degrees (including both permanent staff and contractual employees) currently employed in state management agencies and public institutions in a region at the reporting time.

2. Major classification:

- Gender;

- Ethnicity (Kinh/others);

- Level: Bachelor's/Postgraduate.

- Province/Central City.

3. Year of publication: Year.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and consolidating: The Drug Administration of Vietnam.

6. Units coordinating and providing information:

- Health Departments of provinces and centrally governed cities

- Units under the Ministry of Health;

- Health sector.

0103. The number of pharmacists with bachelor's or postgraduate degrees working in pharmaceutical production and business units.

1. Concept, Calculation Method:

The number of pharmacists with bachelor's or postgraduate degrees working in pharmaceutical production and business units is the total number of pharmacists with bachelor's or postgraduate degrees currently employed in pharmaceutical production and business units in a region at the reporting time.

2. Major classification:

- Gender;

- Ethnicity (Kinh/others);

- Level: Bachelor's/Postgraduate.

- Province/Central City.

3. Reporting Period.: Year.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Health Departments of provinces and centrally governed cities.

0104. Number of pharmacists with bachelor's degree or higher per ten thousand people.

1. Concept, Calculation Method:

The number of pharmacists with bachelor's degree or higher per ten thousand people is the number of pharmacists with bachelor's degree or higher (pharmacist bachelor's degree, master's degree in pharmacy, specialist pharmacist I, specialist pharmacist II, doctorate, professor in pharmacy and equivalent) currently working in the healthcare sector serving 10,000 people in a region at the reporting time.

Calculation formula:

2. Major classification:

Province/Centrally Governed City.

3. Year of publication: Year.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- Health Departments of provinces and centrally governed cities

- Units under the Ministry of Health;

- Health sector.

0105. Number of clinical pharmacists in medical examination and treatment facilities.

1. Concept, Calculation Method:

The number of clinical pharmacists in medical examination and treatment facilities is the total number of pharmacists currently working in the field of clinical pharmacy in medical examination and treatment facilities at the reporting time.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- Health Departments of provinces and centrally governed cities

- Central hospitals/institutes with beds.

- Health sector.

02. DRUG SUPPLY SYSTEM AND RAW MATERIALS FOR DRUG PRODUCTION.

0201. Number of wholesale drug and raw material for drug production establishments.

1. Concept, Calculation Method:

The number of wholesale drug and raw material for drug production establishments is the total number of establishments licensed to operate in wholesale drug and raw material for drug production according to current regulations.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Health Departments of provinces and centrally governed cities.

0202. Number of pharmacies.

1. Concept, Calculation Method:

The number of pharmacies is the total number of retail drug establishments nationwide licensed to operate as pharmacies.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Health Departments of provinces and centrally governed cities.

0203. Number of drug counters.

1. Concept, Calculation Method:

The number of drug counters is the total number of retail drug establishments nationwide licensed to operate as drug counters.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Health Departments of provinces and centrally governed cities.

0204. Number of health station drug cabinets.

1. Concept, Calculation Method:

The number of health station drug cabinets is the total number of retail drug establishments nationwide licensed to operate as health station drug cabinets.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Health Departments of provinces and centrally governed cities.

0205. Number of retail drug establishments per ten thousand people.

1. Concept, Calculation Method:

The number of retail drug establishments per ten thousand people is the number of retail drug establishments (including pharmacies, drug counters, and health station drug cabinets) serving the public, licensed by competent authorities, per ten thousand people.

Calculation formula:

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Health Departments of provinces and centrally governed cities.

0206. Number of drug and raw material for drug production manufacturing establishments.

1. Concept, Calculation Method:

The number of drug and raw material for drug production manufacturing establishments is the total number of drug and raw material for drug production manufacturing establishments in Vietnam licensed by the Drug Administration of Vietnam to operate under Good Manufacturing Practice (GMP) standards still in effect.

2. Major classification:

- Drug production (chemical drugs/herbal drugs/vaccines)/raw materials for drug production.

- Location of establishment in Northern/Middle/Southern regions.

- Establishment with domestic investment/joint venture/foreign investment.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

0207. Number of drug and raw material for drug production testing establishments meeting Good Laboratory Practice (GLP) standards.

1. Concept, Calculation Method:

The number of drug and raw material for drug production testing establishments meeting Good Laboratory Practice (GLP) standards is the total number of drug and raw material for drug production testing establishments in Vietnam licensed by the Drug Administration of Vietnam to operate under GLP standards still in effect.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

0208. Number of drug and raw material for drug production storage service establishments.

1. Concept, Calculation Method:

The number of drug and raw material for drug production storage service establishments is the total number of drug and raw material for drug production storage service establishments in Vietnam licensed by the Ministry of Health to operate under Good Storage Practice (GSP) standards for drug and raw material for drug production.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

- Pharmaceutical and cosmetic statistical reporting system.

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Management Department.

0209. Number of drug and raw material for drug production import establishments.

1. Concept, Calculation Method:

The number of drug and raw material for drug production import establishments is the total number of establishments nationwide licensed to import drugs and raw materials for drug production.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

0210. Number of bioequivalence testing service establishments for drugs.

1. Concept, Calculation Method:

The number of bioequivalence testing service establishments for drugs is the number of establishments engaged in the business of bioequivalence testing services for drugs licensed by the Ministry of Health to operate under Good Laboratory Practice (GLP) standards for bioanalytical phase and/or Good Clinical Practice (GCP) standards still in effect.

2. Major classification:

- Subordinate units of Institutes/Businesses.

- Units implementing both GLP and GCP/Units implementing GLP and collaborating with other GCP units.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

03. DRUG REGISTRATION MANAGEMENT.

0301. Number of drugs with valid registration certificates for circulation.

1. Concept, Calculation Method:

The number of drugs with valid registration certificates for circulation is the total number of drugs (both domestically produced and imported) with valid registration certificates for circulation during the reporting period.

2. Major classification:

- Chemical drugs, radioactive drugs (domestically produced/imported);

- Herbal drugs (domestically produced/imported);

- Vaccines (domestically produced/imported);

- Biological products (excluding in vitro diagnostic biological products) (domestically produced/imported).

3. Reporting Period.: Year.

4. Data source:

Administrative Data.

5. Unit responsible for collecting and compiling: Drug Management Department.

0302. Number of active pharmaceutical ingredients registered for circulation in Vietnam.

1. Concept, Calculation Method:

The number of active pharmaceutical ingredients registered for circulation in Vietnam is the total number of active pharmaceutical ingredients registered for circulation in Vietnam during the reporting period.

2. Major classification:

Domestically produced/imported.

3. Reporting Period.: Year.

4. Data source:

Administrative Data.

5. Unit responsible for collecting and compiling: Drug Management Department.

04. DRUG USE IN HEALTHCARE FACILITIES.

0401. Quantity of domestically produced drugs winning bids.

1. Concept, Calculation Method:

The quantity of domestically produced drugs winning bids is the total number of drug items produced domestically that have won bids for use in healthcare facilities (including national centralized bidding, local centralized bidding, and self-bidding by healthcare facilities).

2. Major classification:

Central/provincial line.

3. Year of publication: 06 months.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- Vietnam Social Security;

- Health Departments of provinces/cities directly under the Central Government;

- Central hospitals/institutes with beds.

- Health sector.

0402. Proportion of domestically produced pharmaceutical items winning bids

1. Concept, Calculation Method:

The proportion of domestically produced pharmaceutical items winning bids is the total number of domestically produced pharmaceutical items winning bids at healthcare facilities compared to the total number of pharmaceutical items winning bids at healthcare facilities.

Calculation formula:

2. Major classification:

Central/provincial line.

3. Reporting Period.: 06 months.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- Health Departments of provinces/cities directly under the Central Government;

- Central hospitals/institutes with beds.

- Health sector.

0403. Value of pharmaceuticals used in healthcare facilities

1. Concept, Calculation Method:

The value of pharmaceuticals used in healthcare facilities is the total amount of money (in VND) spent on patients for pharmaceuticals at healthcare facilities.

2. Major classification:

- Domestically produced pharmaceuticals/imported pharmaceuticals;

- Original drug pharmaceuticals/generic pharmaceuticals;

- Chemical pharmaceuticals/herbal medicines;

- Antibiotics/vaccines/biological products/radiopharmaceuticals and labeled compounds;

- Value of health insurance pharmaceuticals used in healthcare facilities of the health sector/private healthcare

- Province/Central City.

3. Reporting Period.: 06 months.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- Health Departments of provinces/cities directly under the Central Government;

- Central hospitals/institutes with beds.

- Health sector.

0404. Proportion of the value of domestically produced pharmaceuticals used in healthcare facilities

1. Concept, Calculation Method:

The proportion of the value of domestically produced pharmaceuticals used in healthcare facilities is the ratio between the total amount of domestically produced pharmaceuticals used at healthcare facilities and the total amount of pharmaceuticals used at healthcare facilities.

Calculation formula:

2. Major classification:

Central/provincial/district line.

3. Reporting Period.: 06 months

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- Health Departments of provinces/cities directly under the Central Government;

- Central hospitals/institutes with beds.

- Health sector.

0405. Value of pharmaceuticals received as aid and humanitarian assistance by healthcare facilities

1. Concept, Calculation Method:

The value of pharmaceuticals received as aid and humanitarian assistance by healthcare facilities is the total amount of money and value of pharmaceuticals (in VND) that healthcare facilities receive from domestic and foreign organizations and individuals.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: 06 months.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Department of Planning and Finance (Ministry of Health).

6. Units coordinating and providing information:

- Health Departments of provinces/cities directly under the Central Government;

- Central hospitals/institutes with beds.

- Health sector.

05. VALUE OF DOMESTICALLY PRODUCED PHARMACEUTICALS, EXPORTS AND IMPORTS, AND USE OF PHARMACEUTICALS

0501. Value of domestically produced pharmaceuticals

1. Concept, Calculation Method:

The value of domestically produced pharmaceuticals is the total production revenue of all pharmaceutical manufacturing enterprises nationwide.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: 06 months

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Pharmaceutical production facilities and raw material production facilities in Vietnam.

0502. Value of pharmaceutical exports

1. Concept, Calculation Method:

The value of pharmaceutical exports is the export value of the country calculated based on the export contract value converted into USD and VND.

2. Major classification:

Province/Centrally Governed City.

3. Year of publication: 06 months.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Exporting and importing pharmaceutical facilities and raw material production facilities.

0503. Value of imported finished pharmaceuticals

1. Concept, Calculation Method:

The value of imported finished pharmaceuticals is the import value of finished pharmaceuticals nationwide calculated based on the import contract value converted into USD and VND.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: 06 months

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Exporting and importing pharmaceutical facilities and raw material production facilities.

0504. Value of imported raw materials for pharmaceuticals

1. Concept, Calculation Method:

The value of imported raw materials for pharmaceuticals is the import value of raw materials for pharmaceuticals nationwide calculated based on the import contract value converted into USD and VND.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: 06 months.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Exporting and importing pharmaceutical facilities and raw material production facilities.

0505. Average pharmaceutical expenditure per capita

1. Concept, Calculation Method:

Average pharmaceutical expenditure per capita is the total pharmaceutical sales revenue on the market in a year divided by the average population of that year.

_{Calculation formula:}

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: 06 months

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Pharmaceutical production, exporting, and importing facilities and raw material production facilities.

06. MANAGEMENT OF QUALITY OF CIRCULATING PHARMACEUTICALS AND RAW MATERIALS FOR PHARMACEUTICALS

0601. Number of pharmaceutical samples and raw material samples taken and tested for quality by state inspection agencies

1. Concept, Calculation Method:

The number of pharmaceutical samples and raw material samples taken and tested for quality by state inspection agencies is the total number of pharmaceutical and raw material samples collected and tested for quality by the National Institute of Pharmaceutical Inspection and Provincial/City Centers for Pharmaceutical Inspection at pharmaceutical production, export, import, wholesale, retail, and usage facilities.

This number does not include additional samples taken for re-evaluation of previous testing results.

2. Major classification:

- Samples taken by the National Institute of Pharmaceutical Inspection/Provincial/City Centers for Pharmaceutical Inspection;

- Samples tested by Institutes and Centers for Inspection meeting GLP standards/ Centers for Inspection not meeting GLP standards.

- Samples taken from Class 1 facilities/Class 2 facilities, including:

+) Class 1 facility: Production facility, import facility, pharmaceutical storage service facility, wholesale facility, medical examination and treatment facility level II or higher;

+) Class 2 facility: Retail pharmaceutical facility, medical examination and treatment facility level III, IV.

- Domestically produced pharmaceuticals/imported pharmaceuticals;

- Chemical pharmaceuticals, biological products/herbal medicines.

3. Reporting Period.: 06 months.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- National Institute of Pharmaceutical Inspection;

- Ho Chi Minh City Center for Pharmaceutical Inspection;

- Provincial/City Centers for Pharmaceutical Inspection directly under the Central Government.

0602. Proportion of pharmaceutical samples failing quality tests out of the total number of samples taken for quality testing

1. Concept, Calculation Method:

The proportion of pharmaceutical samples failing quality tests out of the total number of samples taken for quality testing is the ratio of the number of pharmaceutical samples failing to meet registered quality standards over the total number of pharmaceutical samples taken by state inspection agencies for quality testing.

Calculation formula:

2. Major classification:

- Chemical pharmaceuticals, biological products/herbal medicines.

- Samples taken from Class 1 facilities/Samples taken from Class 2 facilities.

- Pharmaceuticals failing quality tests at Level 1/Level 2/Level 3.

- Samples tested by Institutes and Centers for Inspection meeting GLP standards/ Centers for Inspection not meeting GLP standards.

The GLP/Central Testing Laboratory has not met the GLP standards.

3. Reporting Period.: 06 months.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Administration of Vietnam

6. Units coordinating and providing information:

- National Institute of Pharmaceutical Inspection;

- Ho Chi Minh City Center for Pharmaceutical Inspection;

- Provincial/City Centers for Pharmaceutical Inspection directly under the Central Government.

0603. Proportion of raw material samples failing quality tests

1. Concept, Calculation Method:

The proportion of raw material samples failing quality tests is the ratio of the number of raw material samples failing to meet quality standards over the total number of raw material samples taken and tested for quality by state inspection agencies.

Calculation formula:

2. Major classification:

Raw materials failing quality tests at Level 1/Level 2/Level 3.

3. Reporting Period.: 06 months.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Administration of Vietnam

6. Units coordinating and providing information:

- National Institute of Pharmaceutical Inspection;

- Ho Chi Minh City Center for Pharmaceutical Inspection;

- Provincial/City Centers for Pharmaceutical Inspection directly under the Central Government.

0604. Proportion of domestically produced pharmaceuticals failing quality tests

1. Concept, Calculation Method:

The proportion of domestically produced pharmaceuticals failing quality tests is the ratio of the number of domestically produced pharmaceutical samples failing to meet registered quality standards over the total number of pharmaceutical samples taken and tested for quality by state inspection agencies.

Calculation formula:

2. Major classification:

- Chemical pharmaceuticals, biological products/herbal medicines.

- Samples taken from Class 1 facilities/Samples taken from Class 2 facilities.

- Pharmaceuticals failing quality tests at Level 1/Level 2/Level 3.

3. Reporting Period.: 06 months.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Administration of Vietnam

6. Units coordinating and providing information:

- National Institute of Pharmaceutical Inspection;

- Ho Chi Minh City Center for Pharmaceutical Inspection;

- Provincial/City Centers for Pharmaceutical Inspection directly under the Central Government.

0605. Proportion of imported pharmaceuticals failing quality tests

1. Concept, Calculation Method:

The ratio of imported drugs not meeting quality standards is the proportion of the quantity of imported drug samples not meeting registered quality standards over the total quantity of drug samples taken and tested for quality by state inspection agencies.

Calculation formula:

2. Major classification:

- Chemical pharmaceuticals, biological products/herbal medicines.

- Drug samples taken from first-class facilities / Drug samples taken from second-class facilities.

- Pharmaceuticals failing quality tests at Level 1/Level 2/Level 3.

3. Reporting Period.: 06 months.

4. Data source:

- Reporting system for statistics in the field of drugs and cosmetics;

- Administrative data.

5. Unit responsible for collecting and compiling: Drug Administration of Vietnam

6. Units coordinating and providing information:

- National Institute of Pharmaceutical Inspection;

- Ho Chi Minh City Center for Pharmaceutical Inspection;

- Provincial/City Centers for Pharmaceutical Inspection directly under the Central Government.

0606. Ratio of counterfeit drugs

1. Concept, Calculation Method:

The ratio of counterfeit drugs is the proportion of batches of counterfeit drugs detected over the total number of drug samples taken for quality testing.

Calculation formula:

2. Major classification:

- Counterfeit drugs produced by domestic manufacturing facilities/foreign facilities;

- Counterfeit drugs without active ingredients/counterfeit packaging labels.

3. Year of publication: Year.

4. Data source:

Reporting and statistical system for pharmaceuticals-cosmetics sector

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- National Institute of Pharmaceutical Inspection;

- Ho Chi Minh City Center for Pharmaceutical Inspection;

- Provincial/City Centers for Pharmaceutical Inspection directly under the Central Government.

07. PHARMACEUTICAL ALERT

0701. Number of adverse drug reaction reports received

1. Concept, Calculation Method:

- The number of adverse drug reaction reports received is the total number of adverse drug reaction reports collected during the reporting period.

- Adverse drug reactions are unwanted and harmful effects on health that may occur at normal dosages.

2. Major classification:

- Medical examination and treatment facilities/drug manufacturing and trading facilities.

- Province/Central City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

0702. Number of pharmaceutical alert information processed

1. Concept, Calculation Method:

The number of pharmaceutical alert information processed is the total number of information related to drug safety including adverse drug reactions, errors related to drugs, and issues regarding drug quality (counterfeit drugs, substandard drugs) collected and processed by the Drug Administration during the reporting period.

2. Major classification:

Medical examination and treatment facilities/drug manufacturing and trading facilities/other units.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

08. COSMETIC PRODUCTION AND DISTRIBUTION MANAGEMENT

0801. Number of cosmetic product notification forms for imported cosmetics issued with registration numbers

1. Concept, Calculation Method:

The number of cosmetic product notification forms for imported cosmetics issued with registration numbers is the total number of notification forms for cosmetics produced abroad and issued with registration numbers for importation and circulation in Vietnam within the year.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

0802. Number of cosmetic product notification forms for domestically produced cosmetics issued with registration numbers

1. Concept, Calculation Method:

The number of cosmetic product notification forms for domestically produced cosmetics issued with registration numbers is the total number of notification forms for cosmetics produced domestically and issued with registration numbers for production and circulation in Vietnam within the year.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information: Health Departments of provinces/cities directly under the Central Government.

0803. Value of imported cosmetics

1. Concept, Calculation Method:

The value of imported cosmetics is the total value of cosmetics produced abroad and imported for circulation in Vietnam within the year.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

6. Units coordinating and providing information:

- Enterprises named in the notification forms for imported cosmetics;

- General Department of Customs.

0804. Value of domestically produced cosmetics

1. Concept, Calculation Method:

The value of domestically produced cosmetics is the total value of cosmetics produced domestically and circulated in Vietnam within the year.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and consolidating: The Drug Administration of Vietnam.

6. Units coordinating and providing information:

- Health Departments of provinces/cities directly under the Central Government;

- Domestic cosmetic manufacturing enterprises.

0805. Number of facilities announcing imported cosmetics

1. Concept, Calculation Method:

The number of facilities announcing imported cosmetics is the total number of facilities named in the notifications and responsible for bringing imported cosmetic products to the market in Vietnam up to the end of the reporting year.

2. Major classification:

Province/Centrally Governed City.

3. Reporting Period.: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and compiling: Drug Management Department.

0806. Number of facilities announcing domestically produced cosmetics

1. Concept, Calculation Method:

The number of facilities announcing domestically produced cosmetics is the total number of facilities named in the notifications and responsible for bringing domestically produced cosmetic products to the market in Vietnam up to the end of the reporting year.

2. Major classification:

Province/Centrally Governed City.

3. Year of publication: Year.

4. Data source:

Pharmaceutical and cosmetic statistical reporting system.

5. Unit responsible for collecting and consolidating: The Drug Administration of Vietnam.

6. Units coordinating and providing information: Health Departments of provinces/cities directly under the Central Government.