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ALTERATION IN LEGAL REGULATION FOR REGISTERING DRUG IN VIETNAM

The pharmaceutical industry plays an important role in the development of human resources for the country. We all know that, if the training of pharmacists in schools and centers is good, pharmacists after graduation with high professional knowledge and skills will make a positive contribution to medical examination and treatment, improving the quality of human resources for the country. High-quality workers will have enough health, work diligently, and produce to maximize their creativity at work, which is a launching pad for them to affirm their talents and contribute to society. In order to better manage and facilitate the development of Vietnam's pharmaceutical industry, the 2016 Pharmacy Law and Decree 54/2017/ND-CP guiding the Pharmacy Law were issued effective in 2017 to manage better than the development of Vietnam's pharmaceutical industry.

I. Legal basis
- Vietnam Law on Pharmacy of 2016 
- Decree 54/2017/ND-CP Guidelines for Implementation of The Law on Pharmacy

With the effect of The 2016 Law on Pharmacy as well as the subsequent Decree 54 Guidelines for Implementation of The Law on Pharmacy, Pharmaceuticals companies were waiting on the release of new legislation in replace of Circular 44. Eventually, with the issue of Circular No. 32/2018/TT-BYT, the pharmaceutical industry has taken a step forward in the process of drug registration.  

Circular 32/2018/TT-BYT stipulating the registration of the circulation of drugs and medicinal ingredients according to the trend of international integration, ensuring the trend of harmony between ASEAN and the World Health Organization. The Circular was issued on November 12, 2018, and took effect on September 1, 2019.

Circular 32 provides full provisions on the following issues
Dossier and procedures for granting, extending, changing, supplementing, withdrawing circulation registration certificates of pharmaceutical drugs, vaccines, biological products, herbal drugs and medicinal ingredients (pharmaceuticals, semi-finished herbal medicinal products), excipients, capsule shells) for human use in Vietnam;

Requirements on clinical data to ensure safety and effectiveness in drug registration dossiers;

Criteria for determining cases of exemption from the trial, exemption from some stages of a clinical trial in Vietnam, drugs requiring phase 4 clinical trial;

Principles of organization and operation of experts appraising dossiers of application for issuance, extension, change, or supplementation of circulation registration certificates of drugs and medicinal ingredients;

Principles of organization and operation of experts appraising dossiers of application for import licenses of drugs without circulation registration certificates for the cases specified at Point a, Clause 43, Article 5 of Decree No. 155/2018 /ND-CP;

Principles of organization and operation of the Advisory Council for issuance of circulation registration certificates of drugs and medicinal ingredients;

Procedures for appraising the application for issuance, extension, change, or supplementation of the certificate of free sale of drugs and medicinal ingredients; the order of appraisal of import dossiers of drugs without circulation registration certificates.

The new laws have also increased the standards for Certificates of Pharmaceutical Product (CPP). For example, instead of just one CPP granted by the country of manufacture, a new chemical entity registration dossier now requires at least two CPPs provided by the country of manufacture and a Stringent Regulatory Authority (SRA).

Drug regulatory agencies classified by the World Health Organization (WHO) as on the SRA list include:

Members of ICH before October 23, 2015, include: US Food and Drug Administration (US-FDA), Drug Administration of the European Commission countries (European Commission), Agency Medicines and Health Products Regulatory Authority of the United Kingdom (MHRA), Japan Medicines and Medical Devices Agency (PMDA);

Observer members of ICH before October 23, 2015, include: Drug Administration of the European Free Trade Association (EFTA-European Free Trade Association) with representatives of the Swiss Drug Administration (Swissmedic) and Health Canada (Health Canada);

Members with the association and mutual recognition agreements with ICH Members before October 23, 2015, include Australia, Iceland, Liechtenstein, and Norway.

Circular 32, unlike Circular 44, does not address intellectual property issues with regard to registered pharmaceuticals. Circular 32, on the other hand, states that the registrant is solely responsible for the IP concerns relating to its registered medications. Furthermore, the new circular and other relevant legal papers no longer contain clauses prohibiting the withdrawal of a marketing authorization number when authorities determine that a drug infringes on intellectual property rights. In terms of intellectual property protection in Vietnam, this is a step backward.


 

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