Amending many policies on registration of circulation of drugs and pharmaceutical ingredients

Dr. Nguyen Van Loi, Head of the Drug Registration Department (Drug Administration Department - Ministry of Health ) said: After more than 7 years of implementing the 2016 Pharmacy Law, in addition to the achieved results, a number of regulations related to drug circulation registration and drug ingredients have revealed shortcomings that need to be adjusted.

Regarding the dossier, order and procedures for extending the validity of the Certificate of Circulation Registration for drugs and pharmaceutical ingredients, it is stipulated that all dossiers for extending the Certificate of Circulation Registration must go through the appraisal and approval process of the Advisory Council for granting the Certificate of Circulation Registration. This provision of the 2016 Pharmacy Law has contributed to ensuring the quality, safety and effectiveness of drugs in circulation. However, for drugs in circulation on the market that do not receive feedback related to quality, safety for users or do not have recommendations from the World Health Organization, it is still necessary to go through the Advisory Council, which may increase the processing time and overload the Advisory Council.

Therefore, it is necessary to differentiate the dossiers for renewing the Certificate of Circulation Registration that must or must not be assessed and approved by the Advisory Council for granting the Certificate of Circulation Registration to ensure the continuous circulation of drugs and pharmaceutical ingredients while still ensuring safety and effectiveness for users.

On the other hand, the regulation on dossiers for extending the validity of the Circulation Registration Certificate requires submitting six types of documents, mainly administrative documents. Having to submit many documents in the dossier has led to a waste of time and resources for businesses when preparing dossiers as well as creating pressure for the management agency in having to appraise and approve dossiers. Currently, the Ministry of Health has deployed an online licensing system and in the near future will connect the national pharmaceutical database, so these documents can be completely looked up, so there is no need to request resubmission.

The change and addition of the Certificate of Circulation of Drugs and Pharmaceutical Ingredients must be approved by the appraisal of the dossier and consultation of the Advisory Council for the issuance of the Certificate of Circulation of Drugs and Pharmaceutical Ingredients. However, in the current reality, this regulation is unnecessary, causing a waste of time for businesses and at the same time creating pressure on the time to handle administrative procedures for state management agencies in cases of simple administrative changes (change of mailing address, change of name, address of manufacturing facility, drug registration, addition of QR code, etc.) because these changes and additions are not related to the technical expertise, safety and effectiveness of the drug.

Regulations on clinical trials for drugs when registering for circulation for herbal drugs with new combinations of medicinal herbs that have been used as drugs in Vietnam are also not suitable and not completely consistent with the current new drug management mechanism in Vietnam and other countries in the region.

Minister of Health Dao Hong Lan reported, explained, accepted and clarified a number of issues of the Law amending and supplementing a number of articles of the Law on Pharmacy at the meeting on the afternoon of June 26.

Based on the shortcomings, the draft Law amending and supplementing a number of articles of the Law on Pharmacy has made adjustments towards simplifying the dossier for renewal, change and supplement of the Certificate of Circulation Registration of drugs and pharmaceutical ingredients; regulating cases of renewal, change and supplement of the Certificate of Circulation Registration without going through the Advisory Council for the issuance of the Certificate of Circulation Registration or without waiting for the approval of the Ministry of Health to simplify administrative procedures. Notably, reducing the time for processing dossiers of changes and supplements that only need to be announced from 3 months to 15 working days; adding regulations allowing establishments to continue using the Certificate of Circulation Registration after it has expired and has submitted an application for renewal according to regulations until it is renewed or has a document from the Ministry of Health.

Allowing the replacement of the Certificate of Pharmaceutical Product (CPP) with documents proving that the drug is licensed in case it meets the needs of disease prevention and control; exempting from submitting clinical records in the application for a Certificate of Circulation Registration for new drugs (except vaccines) produced domestically with indications for use in preventing and treating group A diseases that have been declared epidemics according to the provisions of law on prevention and control of infectious diseases and have the same active ingredients, dosage forms, routes of administration, and indications as drugs that have been licensed for circulation or licensed for use in emergency cases or licensed for circulation and use with conditions by the strict drug administration agency (SRA).

Regarding the time limit for granting a Certificate of Circulation Registration in reference cases, it shall not exceed 09 months from the date of receiving complete documents for new drugs, reference biological products, similar biological products, and vaccines with a report on the appraisal results of a strict drug administration agency (SRA) according to the regulations of the Minister of Health.

No later than 10 working days from the date of receiving the complete dossier, the Ministry of Health shall appraise the administrative dossier to issue a Certificate of Circulation Registration based on the recognition of the licensing results of the strict drug administration agency (SRA) for the registration dossier of new drugs with indications for use in preventing and treating group A diseases that have been declared epidemics according to the provisions of the law on prevention and control of infectious diseases; assign the drug registration facility to be responsible for the accuracy and legality of the technical dossier and the dossier of assessment of compliance with Good Manufacturing Practices for drug manufacturing facilities. The Ministry of Health shall inspect and evaluate the technical expertise of the technical dossier and the dossier of assessment of compliance with Good Manufacturing Practices for drug manufacturing facilities after issuing the Certificate of Circulation Registration.

Drugs and pharmaceutical ingredients that have been granted a Certificate of Circulation Registration but are not circulated on the market within a period of 5 years from the date of issuance shall not have their Certificate of Circulation Registration extended, except for rare drugs, drugs for the treatment of rare diseases or drugs with no more than 3 valid Certificates of Circulation Registration.

Abolish the regulation on clinical trials for herbal medicines containing new combinations of herbal medicines that have been used as medicines in Vietnam and are indicated for diseases on the list issued by the Minister of Health.

Source: https://nhandan.vn/sua-doi-nhieu-chinh-sach-ve-dang-ky-luu-hanh-thuoc-nguyen-lieu-lam-thuoc-post816365.html