Pharma firms aiming for GMP certificates

14:00 | 23/07/2020
Despite strict requirements, international pharma giants like Novartis, AstraZeneca, and Pfizer are rushing to complete all necessary procedures to receive the most sought-after GMP recognition for their manufacturing sites, signalling a hotter tender market in the months to come.
1501p20 pharma firms aiming for gmp certificates
Illustrative image (Photo: internet)

The Drug Administration of Vietnam (DAV) on July 10 announced Dispatch No.10364/QLD-CL on the list of manufacturing sites that multinational corporations (MNCs) want to be recognised with a GMP qualification. Many of which still need to submit supplementation documents.

Specifically, in Annex 3 of the dispatch, Merck Sharp & Dohme’s (MSD) site, Schering-Plough Labo NV, is requested to supplement some documents to clarify that the facility has productions of suspension dosage form, and small volume emulsions, among others.

Meanwhile, the Ho Chi Minh City representative office of GlaxoSmithKline Pte., Ltd. (GSK), which seeks GMP recognition for the manufacturing site Catalent Belgium SA, is asked to supplement the updated, valid, and legalised GMP certificate. GSK must also further explain the site’s production scale of biological drugs which are not named in its overall records.

Similarly, Pfizer Ltd.’s (Thailand) proposed manufacturing site, Pfizer Manufacturing Belgium NV, is required to explain its production of immunosuppressive drugs and human- or animal-derived substances.

In this race, Zuellig Pharma Pte. Ltd. is seeking GMP qualification for its manufacturing site ZambonSwitzerland Ltd. and should submit supplements and reports on regular check-ups on product quality of sterile drugs.

Other mammoth names in this list include the Ho Chi Minh City representative office of Novartis Pharma Services AG, AstraZeneca Singapore Pte., Ltd., DKSH Singapore Pte., Ltd., and Sanofi-Aventis Singapore Pte., Ltd., among many others.

In particular, Novartis is requested to submit the updated, valid, and legalised GMP certificate for the manufacturing site Glaxo Operations UK Ltd. Meanwhile, similar procedures are required to be performed by AstraZeneca Pharmaceutical Co., Ltd.

According to some MNCs’ representatives, it is not easy for them to fulfil the requirements of the GMP certification, but they are striving to follow these as there is no other choice to join the local drug tenders.

Sanofi, Novartis, GSK, Pfizer, and MSD are also the names in the previous Dispatch No.3518 governing the list of manufacturing sites that were required to make further clarification to receive PIC/S-GMP and EU-GMP acknowledgements. Now, they are seeking for other sites, reflecting their ambition to boost presence in the local lucrative pharmaceutical market.

Branded and imported drugs often remain too expensive for Vietnamese, thus bringing about huge profit for MNCs active in the local market. In the DAV’s July 14 announcement about the tender winners, Novartis, Sanofi, AstraZeneca, MSD, Pfizer, and GE Healthcare were named.

According to the DAV’s statistics, such drugs make up an average of 26 per cent of total health insurance spending. The rate is 47 per cent at central hospitals, and 26 per cent at provincial ones.

The Ministry of Health is to issue a new tender circular in line with the government’s direction to increase local access to quality medicines and to reduce prices, focusing on brand-name drugs, hoping that once issued, more locals will benefit from this and a more competitive tender market will form in the future.

Circular No.15/2019/TT-BYT dated July 2019 regulating drug tenders at public hospitals

Group 1 includes drugs satisfying one of the three following criteria:

* Drugs manufactured entirely by a manufacturing line satisfying EU-GMP requirements or equivalent requirements in a country that is considered a stringent regulatory authority (SRA);

* Drugs on the list of proprietary drugs or reference biological drugs as announced by the Ministry of Health (MoH), except for proprietary drugs on the list of drugs eligible for price negotiation issued by the MoH and with announced price negotiation results; or

* Drugs manufactured entirely in Vietnam that satisfy all following requirements:

- Manufactured drugs satisfying EU-GMP requirements or equivalent requirements that are certified by the DAV to satisfy EU-GMP requirements or equivalent requirements;

- Drugs with granted certificates of free sale by the national drug authority of a country that is considered SRA as specified in Clause 8 of Article 50 of this circular;

- Drugs sold in Vietnam and drugs with granted certificates of free sale by a country that is considered SRA shall have the same dosage form, production process, quality criterion, verification method; active ingredients, excipients shall have the same quality criterion, production facility and production place as specified in Clause 8 of Article 50 of this circular.

Group 2 includes drugs satisfying one of the two following criteria:

* Drugs made entirely by a manufacturing line satisfying EU-GMP requirements or equivalent requirements with granted certificates by the DAV.

* Drugs manufactured entirely by a manufacturing line in a country that is a member state of Pharmaceutical Inspection Co-operation Scheme (PIC/s) and International Conference on Harmonisation (ICH), satisfying PIC/s-GMP requirements with granted certificates by the national drug authority of such country and the DAV.

Group 3 includes drugs manufactured by a manufacturing line satisfying GMP requirements with granted certificates by the DAV with evidence of bioequivalence announced by the DAV.

Group 4 includes drugs manufactured entirely by a manufacturing line in Vietnam satisfying WHO-GMP requirements with granted certificates by the DAV.

Group 5 includes drugs manufactured by a manufacturing line satisfying WHO-GMP requirements with granted certificates by the DAV which are not included in provisions specified in Clauses 1, 2, 3 and 4 of this article.

By Bich Thuy

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