The assessment is carried out in two forms: appraisal of documents related to production conditions and recognition and acknowledgement of inspection and examination results by the state pharmaceutical management agency.
Of the total 151 foreign manufacturing facilities with dossiers requesting assessment this time, 125 facilities were announced to be assessed as meeting GMP. In addition, 26 facilities had incomplete dossiers or documents that did not meet the requirements for dossiers according to regulations, requiring supplementation and explanation.
For example, the dossier of CSPC Ouyi Pharmaceutical Co., Ltd - China (Medlac Pharma Italy Pharmaceutical Manufacturing Co., Ltd. submitted the dossier for publication) needs to supplement documents proving cross-contamination control between anti-cancer drugs/hormonal drugs and conventional drugs.
Or the dossier of Corden Pharma Fribourg SA - Switzerland Production Facility (Fresenius Kabi Vietnam Joint Stock Company submitted the dossier for announcement) was also not qualified because the Inspection Report document had not been consularized and notarized according to regulations.
In addition, the Drug Administration of Vietnam also disagreed with the proposal to announce the additional scope of "chewable tablets" because the Facility had already announced the scope of "tablets" which included the dosage form of chewable tablets.
The dossier of Micro-Sphere SA - Switzerland Manufacturing Facility (ANVO Pharma Canada Inc. submitted the dossier for declaration) needs to supplement technical documents such as the overall factory diagram, detailed diagram of each production area with specific production rooms.
The Drug Administration also requested the facility to explain the inconsistency between the scope stated on the issued GMP Certificate and the General Profile of the manufacturing facility.
Regarding the dossier of the Limited Liability Company "Ozon" - Russia (Nam Thanh Medical Services and Trading Company Limited submitted the dossier for declaration), the Drug Administration requested to supplement the valid GMP Certificate, the inspection report corresponding to the attached GMP certificate and the report on the review of the quality of sterile drugs because the dossier did not meet the requirements and regulations for establishments requesting the declaration of sterile drugs.
In addition, the Department also requested the company to explain its name on the drug registration documents for products manufactured by Limited Liability Company "Ozon"...
The Drug Administration of Vietnam requests that units base on the content that needs to be supplemented and explained in the above list to submit additional documents on the TT48 Public Service System for further consideration and publication.
The updated list of foreign drug and pharmaceutical ingredient manufacturing facilities that meet Good Manufacturing Practices (GMP) is posted on the Online Public Service System. The Departments of Health of provinces and centrally run cities and public health facilities use these lists to consider drug bidding packages in accordance with the provisions of Circular 07/2024/TT-BYT of the Minister of Health on guidelines for drug bidding at health facilities and the provisions of the Law on Bidding.
The Drug Administration of Vietnam notes that drug manufacturing, registration and trading establishments must review and promptly update the GMP compliance status of foreign drug and drug ingredient manufacturing establishments in accordance with the provisions of Point d, Clause 1, Article 100 of Decree No. 54/2017/ND-CP dated May 8, 2017; note that foreign manufacturing establishments whose GMP Certificates have been extended in validity according to the policy during the COVID-19 pandemic period of drug administration agencies of each country.
