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Nearly 10,000 drug registration papers are about to expire

Nearly 10,000 drug registration papers will expire by the end of this year, putting the market at risk of shortage of therapeutic drugs, but until April 21, the Ministry of Health has only extended more than 200 papers.

According to the Law on Pharmacy, drugs that want to be circulated legally on the market must be registered for circulation by enterprises – this is a mandatory condition. The drug circulation license issued by the Ministry of Health is valid for 5 years. When the license expires, the business must apply for an extension, or else the drug must be discontinued. As a result, the domestic drug supply may be affected, leading to a shortage of therapeutic drugs.

The Ministry of Health on April 13 reported to Deputy Prime Minister Vu Duc Dam that there are more than 6,400 registration papers for domestic drugs, nearly 3,000 registration papers for foreign drugs, 351 registration papers for vaccines and biologicals, which will expire on December 31. In addition, the Ministry of Health noted that many drug registration certificates will expire on June 30.

Many questions such as how expired marketing authorizations affect the pharmaceutical market, which drugs are at risk of supply shortages, progress in processing renewal applications, etc. VnExpress raised with the Ministry of Health but has not yet received a response. On the evening of April 21, the Drug Administration of Vietnam announced the extension of 202 certificates of circulation of domestic drugs, of which 193 papers add a period of 5 years, 9 papers add 3 years. Thus, this number of renewals is still very small compared to the number of papers that are about to expire.

Explaining the reason for the delay in the extension of the circulation registration certificate, in a report to the Deputy Prime Minister, the Ministry of Health said that in the past time, it has focused on anti-epidemic, production activities, assessment, certification and legal papers. other reasons stalled. The pharmaceutical business enterprise failed to prepare enough documents to request the extension. In this situation, on the part of the management agency, many experts refuse to appraise the records because of concerns about fake records, difficulties when working in a state of distance…

In terms of procedures, the appraisal process to renew a drug registration certificate takes a long time. A set of dossiers of application for extension has about 15 types of documents, such as: GMP certificate of good manufacturing practice, CPP pharmaceutical certificate, GDP good drug distribution certificate… The Drug Administration of Vietnam appraises and submits it. Advisory Council for grant of drug registration certificates consider licensing within 12 months.

According to the process, if the application is satisfactory, it will be assessed quickly, after 6 months Advice council circulation registration certificate will be issued. In case the application is unsatisfactory, the enterprise must provide additional documents within 12-36 months before it can continue to be considered and resolved.

The Ministry of Health is expected in May to give priority to processing license applications that expire early, and at the same time, proposes to the Government to reduce procedures and allow the validity of the drug registration certificate for 12 months so as not to interrupt the source of the drug. supply. The National Assembly is also proposed to develop a Law amending and supplementing the Law on Pharmacy in the direction of extending the drug registration certificate without requiring appraisal.

In this regard, on April 17, the Government Office announced the conclusion of Deputy Prime Minister Vu Duc Dam, requesting the Ministry of Health and the General Department of Customs to remove problems related to import drug clearance procedures; amending the circular on registration of drug circulation…

Molnupiravir is manufactured at Boston Vietnam Company, Binh Duong, on February 23.  Photo: Quynh Tran

Molnupiravir is manufactured at Boston Vietnam Company, Binh Duong, on February 23. Image: Quynh Tran


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