The Ministry of Health has just issued Circular 08/2022/TT-BYT (“Circular 08”) stipulating the marketing authorization of drugs and medicinal ingredients to replace Circular 32/2018/TT-BYT. Compared to the old circular, Circular 08 has shortened a series of administrative procedures to save time for establishments in marketing authorization of drugs and medicinal ingredients. Some notable new points of Circular 08 are as follows:

Simplify administrative procedures in marketing authorization of drugs and medicinal ingredients

Specifically, the entire drug registration procedure is regulated to apply information technology, from application submission, verification to result return.

In order to enhance harmonization with regulations of countries in the region and the world, especially those related to Certificate of Pharmaceutical Product (CPP), administrative procedures have been simplified such as removing the concept of Reference agency and revised it to the European Medicines Agency (EMA) and Stringent Regulatory Authorities (SRA) concepts as classified by the World Health Organization (WHO). Circular 08 also stipulates that the CPP has sufficient content according to the WHO form published on the WHO website.

At the same time, in order to increase access to drugs, especially new drugs, drugs that meet special treatment needs, Circular 08 does not require 2 CPPs but only 1 CPP from the SRA country. In addition, Circular 08 has removed the authorization letter form, only stipulating the content that must be included in the authorization letter to create favorable conditions for enterprises.

Dossier related to the marketing authorization of drugs and medicinal ingredients are only allowed to be amended and supplemented up to three times.

In order to control the licensing of drugs and facilitate management, Circular 08 stipulates that only two marketing authorizations are issued for drugs of the same manufacturer with the same active ingredient or pharmaceutical ingredients; the same dosage form; route of administration; content active ingredient per unit dose, in which one marketing authorization with a trade name, and one marketing authorization with an international common name. This regulation does not apply to processed drugs and drugs manufactured for export only.

In addition, in order to be consistent with ASEAN regulations, Circular 08 stipulates that small change dossiers only require notification, not appraisal and approval by state management agencies.

Another new point in this Circular is that the establishment is only allowed to amend and supplement no more than three times for the application for issuance, renewal, revision and revocation of marketing authorization of drugs and medicinal ingredients. This regulation aims to enhance the responsibility of drug registration establishments in preparing dossiers, and at the same time to reduce pressure on management agencies due to the poor quality of registration dossiers causing many dossiers to be supplemented many times, prolonging the appraisal time, leading to a large backlog of dossiers.

Minimizing the requirements for renewal applications for the marketing authorization of drugs

Circular 08 allows submission of dossiers in the form of a roll-over, without mandatory submission of test sheets, quality standards and testing methods certified by the National Institute for Control of Vaccines and Biologicals (NICVB) at the time of application for registration of vaccines, antiserum, blood extracts and human plasma.

Circular 08 supplements regulations on the application of barcodes and QR codes on the outer packages of drugs and medicinal ingredients of manufacturers in order to manage, identify and trace the origin of drugs.

Regarding renewal applications for the marketing authorization, Circular 08 has minimized its contents to meet the requirements of the Law on Pharmacy for the documents specified in the application for renewal. On the other hand, Circular 08 clearly stipulates that the establishment does not change the label and instructions for use in the application for renewal. The change of labels, instructions for use, the establishment will submit according to the procedures for changes and supplements after the marketing authorization of drugs is renewal...