Circular No. 05/2010/TT-BYT on guiding the protection of data from clinical trials in drug registration

CIRCULAR

Guidelines for the protection of data from clinical trials in drug registration

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Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Intellectual Property Law No. 50/2005/QH11 dated November 29, 2005, amended and supplemented by Law No. 36/2009/QH12 dated June 19, 2009, amending and supplementing certain articles of the Intellectual Property Law;

Pursuant to the Government Decree No. 188/2007/NĐ-CP dated December 27, 2007 on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Government Decree No. 103/2006/NĐ-CP dated September 22, 2006 detailing and guiding the implementation of certain provisions of the Intellectual Property Law regarding industrial property rights;

The Ministry of Health guides the protection of data from clinical trials in drug registration as follows:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 1. These Circulars guide the requirements and implementation of the protection of data from clinical trials in drug registration.

Article 2. These Circulars apply only to finished drugs containing new active substances and do not apply to drug ingredients.

Article 2. Applicability

These Circulars apply to organizations and individuals, both domestic and foreign, involved in drug registration activities in Vietnam.

Article 3. Explanation of Terms

In this Circular, the following terms are understood as follows:

1. Drug means a substance or mixture of substances intended for human use for the purpose of preventing, treating, diagnosing diseases, or adjusting physiological functions of the body, including finished drugs, drug ingredients, vaccines, medical products, excluding functional foods.

2. Active ingredient (also called pharmaceutical substance) means a substance or mixture of substances with therapeutic activity used in drug production.

3. New active substance means an active substance that has not been granted permission for circulation in Vietnam and has not been granted permission for circulation anywhere in the world for more than 12 months, calculated from the date of submission of the drug registration application containing that active substance in Vietnam.

4. Protection of data, protection of data from clinical trials is understood as the protection of data from pharmaceutical clinical trials during the drug registration process as stipulated in Article 128 of the Intellectual Property Law and Article 20 of the Government Decree No. 103/2006/NĐ-CP dated September 22, 2006 detailing and guiding the implementation of certain provisions of the Intellectual Property Law regarding industrial property rights, hereinafter referred to collectively as protection of data.

5. Registration Circularintention of traditional refers to Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Minister of Health on drug registration.

Article 4. Responsibilities for implementing data protection

The Department of Drug Management is the agency responsible for implementing data protection in drug registration according to these Circulars.

Chapter II
CONDITIONS FOR DATA PROTECTION

Article 5. Data subject to protection

Data subject to protection is clinical trial data of drugs containing new active substances provided by the drug registration applicant in the drug registration dossier (to demonstrate the safety and efficacy of the drug as prescribed in the Registration Circular) and meeting the conditions set out in Article 6 of these Circulars.

Article 6. Conditions for data protection

Data will be protected if it meets all of the following conditions:

It is a trade secret satisfying the protection conditions as stipulated in Clause 23, Article 4 and Article 84 of the Intellectual Property Law;

2. It results from significant effort investment;

3. There is a request for protection as stipulated in Clause 1, Article 7 of these Circulars.

Chapter III
PROVISIONS AND PROCEDURES FOR ACCEPTING APPLICATION FILES FOR DRUG REGISTRATION WITH DATA PROTECTION REQUIREMENTS

Article 7. Conditions for accepting application files for drug registration with data protection requirements

1. Application files for drug registration with data protection requirements, in addition to meeting general requirements for application files as stipulated in the Circular on drug registration, must at least include the following documents:

a) A drug registration form according to Form No. 2A/TT as prescribed in the Circular on drug registration, wherein the drug registration entity indicates its data protection requirement by marking the appropriate box and listing the types of documents containing the protected data.

b) Documents containing the protected data presented in the format of clinical reports as prescribed in the Circular on drug registration.

2. All aforementioned documents must be stamped as confidential, placed in a separate package, sealed, and stamped as confidential.

Article 8. Procedures for accepting application files for drug registration with data protection requirements

Application files for drug registration with data protection requirements are accepted by the Drug Administration Department according to the following procedures:

1. Determine the content of the data protection requirement stated in the drug registration form as prescribed in Clause 1, Article 7 of this Circular.

2. Check the format of the confidential document package before opening the seal and check the format of the documents inside as prescribed in Point b, Clause 1, Article 7 of this Circular.

3. Compare the types of documents in the confidential document package with the types of documents listed in the data protection requirement.

4. Record the data protection requirement in the file acceptance logbook and receipt, and reseal the confidential document package for files that meet the conditions stipulated in Article 7 of this Circular. In cases where the application file for drug registration with data protection requirements does not meet the conditions stipulated in Article 7 of this Circular, the Drug Administration Department will only accept the drug registration application if the registering entity withdraws the data protection requirement.

Chapter IV
IMPLEMENTATION OF DATA PROTECTION

Article 9. Acceptance of Data Protection Requirements

1. For application files for drug registration with data protection requirements that have been accepted (except in the case stipulated in Article 10 of this Circular), the Drug Administration Department accepts the data protection requirement and implements security measures as prescribed in Article 12 of this Circular.

2. The decision to accept the data protection requirement is notified to the drug registration entity by the Drug Administration Department and published on the Drug Administration Department's electronic information website together with the announcement regarding the issuance of the drug marketing authorization number.

Article 10. Refusal to Implement Data Protection

1. In the following cases, the Drug Administration Department refuses to implement data protection:

The data requiring protection does not fall within the scope prescribed in Article 5 of this Circular;

The drug in the application file for drug registration with data protection requirements is refused permission for circulation in Vietnam;

There is evidence to confirm that the data requiring protection does not meet at least one of the data protection conditions stipulated in Article 6 of this Circular;

Implementing data protection has the potential to seriously impact public health.

The notification of refusal to implement data protection is sent by the Drug Administration Department to the drug registration entity along with the announcement regarding the issuance or refusal of the drug marketing authorization number, specifying the reasons for refusal.

Article 11. Third-party opinions on the implementation of data confidentiality

1. From the date the decision to accept the data confidentiality request is published, all organizations and individuals have the right to request the Drug Administration to terminate the implementation of data confidentiality in accordance with Article 14 of this Circular.

2. Requests to terminate the implementation of data confidentiality must be made in writing and accompanied by relevant documents or references to information sources to prove the request according to Model No. 1/TTBMDL prescribed in the Appendix attached to this Circular.

3. Within fifteen working days from the date of receipt of the request to terminate the implementation of data confidentiality, the Drug Administration shall notify in writing the drug registration entity holding the confidential data. Within three months from the date the Drug Administration issues the notification letter, the drug registration entity must provide an explanatory letter, supply necessary documents, and evidence as required in the notification.

4. Based on the results of reviewing the request to terminate the implementation of data confidentiality and the opinions of related parties, if the request is deemed to have a basis, the Drug Administration shall issue a decision to terminate the implementation of data confidentiality and publish that decision on its electronic information website; or issue a decision to refuse termination of the implementation of data confidentiality and notify the organization/person making the request if the request to terminate the implementation of data confidentiality is deemed to lack a basis.

Article 12. Measures for Data Confidentiality

In cases where the data confidentiality request is accepted, the Drug Administration shall implement the following measures:

1. Safeguarding and managing documents containing confidential data in accordance with regulations on managing classified documents.

2. Not allowing any third party to access the confidential data except when the access by the competent authority is for the purpose of reviewing clinical trial results, assessing the safety and efficacy of drugs, or meeting public health protection requirements.

3. Not disclosing the data, except when disclosure is necessary to protect the public.

4. Temporarily not considering granting permission to drug registration entities submitting registration applications later than those with confidential data if the later application uses data still under confidentiality without the consent of the entity holding the confidential data and cannot prove that the data in the later application was independently created without using the confidential data.

Article 13. Duration of Data Confidentiality

The confidentiality measures specified in Clauses 1 to 3 of Article 12 shall apply from the date the data is submitted until the data is disclosed, but shall not exceed the duration stipulated by current regulations on managing classified documents.

The confidentiality measure specified in Clause 4 of Article 12 shall apply from the date the data is submitted until five years from the date the drug registration entity holding the confidential data is granted permission to market the drug.

Article 14. Termination of Implementation of Data Confidentiality

The implementation of data confidentiality may be partially or fully terminated in the following cases:

The data no longer meets the conditions for confidentiality as stipulated in Article 6 of this Circular.

The competent authority has grounds to determine that the drug registration entity holding the confidential data does not have legitimate rights to use the confidential data.

The decision to permit the marketing of the drug with confidential data is no longer valid, or the drug registration number is withdrawn, or the drug registration entity voluntarily requests withdrawal of the registration number.

The competent authority issues a decision mandating the transfer of rights to use the patent related to the drug with confidential data.

The competent authority resolves complaints and issues a decision regarding the termination of the validity of the decision accepting the confidentiality request.

Terminating the implementation of data confidentiality is necessary to protect public health and meet urgent societal needs.

Chapter V
RIGHTS AND OBLIGATIONS OF ENTITIES WITH CONFIDENTIAL DATA

Article 15. Rights of entities with confidential data

Entities registering drugs with confidential data have the following rights:

1. To prevent other drug registration entities from using confidential data for unfair commercial purposes, including the unauthorized use of such data to submit drug registration applications.

2. To lodge complaints with the Drug Administration Department when there is suspicion that confidential data has been disclosed or used improperly to submit drug registration applications.

Article 16. Obligations of entities with confidential data

Entities registering drugs with confidential data have the following obligations:

1. To prove their entitlement to confidential data and to demonstrate that the data meets the conditions for confidentiality as required by the Drug Administration Department in cases stipulated in Clause 3, Article 11 of this Circular.

2. To prove that confidential data has been disclosed and/or used improperly for unfair commercial purposes when exercising their rights as provided for in Article 15 of this Circular.

Chapter VI
IMPLEMENTATION

Article 17. Effective Date

1\. This Circular takes effect forty-five days from the date of issuance.

2. This Circular replaces Decision No. 30/2006/QĐ-BYT dated September 30, 2006, issued by the Minister of Health on the Regulation on Confidentiality of Data for Drug Registration Files. Drug registration files requesting data confidentiality submitted to the Drug Administration Department before the effective date of this Circular shall be reviewed and responded to according to the provisions of the Regulation on Confidentiality of Data for Drug Registration Files issued together with Decision No. 30/2006/QĐ-BYT dated September 30, 2006, by the Minister of Health.

3. In case of any difficulties during implementation, organizations and individuals are requested to promptly report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.