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|Sanofi makes second run for EU-GMP recognition|
Sanofi Vietnam, which seeks PIC/S-GMP and EU-GMP recognition from the Ministry of Health’s Drug Administration of Vietnam (DAV) for the manufacturing site Sanofi Vietnam Shareholding Company (SVN), is pinning high hopes on the new DAV approval. Previously, Sanofi Vietnam failed to get the full qualification, as shown in Annex 2 of the DAV’s Dispatch No.3518 from April.
Haissam Chraiteh, Sanofi Indochina general director, told VIR, “We worked with the Therapeutic Goods Administration (TGA) in Australia and in May 2020, we re-submitted the documents to the DAV for EU-GMP recognition.”
“We are waiting for the approval from the DAV. Sanofi will always comply with local regulations to ensure our sustainable development in the market,” he added.
According to Sanofi Vietnam, SVN’s application for EU-GMP recognition was thrown back due to the lack of a certification with wet-ink signature and stamp from the TGA, the owner of the EU-GMP certificate of SVN.
“The industrial sites of Sanofi Vietnam already have the PIC/S-GMP and we aim to get the EU-GMP recognition in the near future,” the general director elaborated.
“Both of PIC/S-GMP and EU-GMP are great examples demonstrating our commitment to bringing high-quality pharmaceutical products to Vietnamese people,” he added.
Similarly, Novartis Pharma Services AG site, which has announced the approval of the GMP qualifications for Lek Pharmaceuticals, may continue to seek the valuable PIC/S-GMP and EU-GMP acknowledgements.
Also in Dispatch No.3518 by DAV, Novartis is asked to give further clarification regarding the company submitting a general file of the manufacturing establishment showing the manufacturing of dosage forms without special requirements.
Novartis was also required to provide an inspection report or certificate of pharmaceutical product of a GMP certification agency, clearly showing the dosage forms without special requirements within the scope of certification.
It remains unclear whether the Novartis Pharma Services AG site has clarified all details and re-submitted its dossier to the DAV.
Together with Sanofi and Novartis, a number of the world’s pharmaceutical leaders such as Pfizer, F. Hoffmann-La Roche AG, Merck Sharp & Dohme Corporation, Santen Pharmaceutical Co., Ltd., Abbott Laboratories (Singapore) Plc., and Dr. Reddy’s Laboratories Ltd.-FTO-3 are also striving to attain acknowledgement of their certifications.
Pharmatis proposed by Abbott Laboratories and Dr. Reddy’s were also on the list of those failing to receive the standards recognition.
Multinationals are showing increasing gusto for GMP recognition in the wake of high profits reported from tenders of brand-name drugs in circulation at public hospitals which cost 10-20 times more than generic products and a potential revision of Circular No.15/2019/TT-BYT dated July 2019 regulating drug tenders at public hospitals.
Under Circular 15, drug tenders are divided into tenders for brand-name drugs and others for generic drugs. For tenders for brand-name drugs or equivalent drugs, drugs shall satisfy the two following criteria. The first is that the drugs are on the list of brand-name drugs or equivalents announced by the Ministry of Health. And the second is the drugs manufactured entirely in countries considered Stringent Regulatory Authorities (SRA) (see box).
Meanwhile, tenders of generic drugs are divided into five groups. Group 1 includes drugs manufactured entirely by a manufacturing line satisfying EU-GMP requirements or equivalent requirements in a country that is considered SRA.
Group 2 includes drugs manufactured in countries which are members of the PIC/S-GMP and the International Conference on Harmonization (ICH). The pharmaceuticals also have to have the recognition of PIC/s-GMP standards by authorised agencies of the relevant countries, and announcement of PIC/s-GMP qualification by the DAV.
The PIC/S-GMP is a non-binding, informal co-operation arrangement between regulatory authorities in the field of GMP of medicinal products for human or veterinary use. It is open to any authority with a comparable GMP inspection system. PIC/S presently comprises 53 participating authorities from all over the world.
Meanwhile, Group IV includes the drugs manufactured in production facilities in Vietnam that have WHO-GMP recognition from the DAV. And Group V includes drugs manufactured by a manufacturing line satisfying WHO-GMP requirements and granted certificates by the drug authority of Vietnam and not included in groups 1, 2, 3 and 4.
Currently, the DAV is revising Circular 15 and is mulling over whether to put PIC/S-GMP drugs into Group 2 or Group 4. An official from the Ministry of Health said, “PIC/S-GMP is widely present across the globe, including countries with cheap drugs. Therefore, any revision of the circular needs to be the result of careful deliberation to ensure drug quality.
The list of countries that are considered SRA under Circular No. 32/2018/TT-BYT dated November 12, 2018 on marketing authorisation of drugs and medicinal ingredients
- A member of ICH before October 23, 2015, including: US-FDA, drug regulatory authorities of European Commission, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals Medical Devices Agency (PMDA);
- An ICH (International Conference on Harmonization) observers before October 23, 2015, including: EFTA- European Free Trade Association (EFTA), Swissmedic and Health Canada;
- A regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement before October 23, 2015, including: Australia, Iceland, Liechtenstein and Norway.