Drugmakers fight to attain approval

Switzerland’s drug maker Novartis Pharma Services AG has announced a GMP qualification for Lek Pharmaceuticals d.d. within the scope of certification for medicines in Vietnam,

but doubts have been raised about recognition in regards to the valuable and much-sought-after PIC/S-GMP and EU-GMP standards.

1498p17 drugmakers fight to attain approval
Confusion reigns over the status of certification for Novartis’ Lek arm, Photo: Le Toan

The Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH) has announced the list of foreign-invested manufacturing factories failing to attain PIC/S-GMP and EU-GMP recognition, with some being required to make further clarifications. They include Novartis Pharma Services AG.

Specifically, in Annex 2 of the DAV’s Dispatch No.3518, Novartis Pharma Services AG site with the registered name Lek Pharmaceuticals d.d. is required to give further clarification regarding the company submitting a general file of the manufacturing establishment showing the manufacture of dosage forms without special requirements.

Novartis was also asked to provide an inspection report, or CPP certificate of a Good Manufacturing Practice (GMP) certification agency, clearly showing the dosage forms without special requirements within the scope of certification.

A representative of Novartis Vietnam Co., Ltd, told VIR, “Novartis appreciates the MoH’s transparency with regards to the announcement, which shows the prudent-monitored operations of the industry, and makes it convenient for companies and the community to have fast access to sufficient information and guidance from the MoH during the implementation of the process.”

The representative also elaborated, “As one of the leading global pharmaceutical companies with operations in Vietnam, we comply with all regulations and guidance from the MoH. As of now, the DAV and MoH have approved and announced the GMP qualification for Lek Pharmaceuticals within the appropriate scope of certification for our medicines in Vietnam.”

Despite Novartis’ announcement of the GMP qualification, it remains unclear whether the manufacturing site gets the high-in-demand PIC/S-GMP and EU-GMP certifications.

GMP is a basic standard, in a system for ensuring products are consistently made and controlled according to quality standards. It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. In Vietnam in 2004, the MoH issued Decision No.3886/2004/QD-BYT implementing the principles and standards of good manufacturing practices.

For western medicines, by the end of 2010, all enterprises producing external medicines and medicinal drug had to achieve GMP-WHO standards at least.

 

Meanwhile, PIC/S-GMP and EU-GMP are higher-standard certifications than GMP. EU-GMP certification is the highest recognition available by companies in the pharmaceutical space, while the PIC/S-GMP is a non-binding, informal co-operative 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.

On receiving the EU-GMP and PIC/S-GMP certifications, drugs channels can gain advantages and high profit in tenders in Group 1 of brand-name drugs which go to the hospital system, or the ethical drugs channel, which is the most profitable segment.

At present, there is no difference in tax incentive treatments in domestically-owned and foreign-invested facilities conducting outsourcing in Vietnam, all being subject to VAT exemption. Together with that exemption, currently the cost of brand-name drugs is 10-20 times higher than generic products, thus bringing in high profit for multinational corporations.

In the wake of the advantages, multinationals are rushing to seek PIC/S-GMP and EU-GMP recognition for their manufacturing sites. Besides Novartis, other famous multinational corporations in the race include GlaxoSmithKline, Sanofi, F.Hoffmann-La Roche Ltd., and more.

However, the path is not rosy for all of them. In the 72nd list of application for the announcement of manufacturers with PIC/S-GMP and EU-GMP qualifications which meet or did not meet requirements announced by the DAV-MoH in April, 64 applications require additional dossiers/clarifications.

French pharmaceutical giant Sanofi Vietnam Shareholding Company, proposed by Sanofi Vietnam, and Pharmatis, proposed by Abbott Laboratories Singapore Plc. and Dr. Reddy’s Laboratories Ltd.-FTO-3, are also on the list of those failing to receive the standards recognition. VIR

Bich Thuy

Gradual but radical changes set to sweep pharmaceutical landscape

Gradual but radical changes set to sweep pharmaceutical landscape

The upcoming implementation of the EU-Vietnam Free Trade Agreement (EVFTA) is expected to transform the competitive landscape of Vietnam’s pharmaceutical and medical industry. 

Vietnam makes big investments in biomedical pharmaceutical research

Vietnam makes big investments in biomedical pharmaceutical research

Deputy Minister of Science and Technology Pham Cong Tac emphasized the significance of long-term investment in research.

 
 

Other News

.
Businesses in Hanoi’s Old Quarter shutdown amid COVID-19 fears
Businesses in Hanoi’s Old Quarter shutdown amid COVID-19 fears
BUSINESSicon  02/08/2020 

The Hanoi People's Committee has moved to require all shops throughout Hanoi’s Old Quarter to close as of midnight on August 1 due to fears regarding recent developments relating to COVID-19 epidemic.

Reality and vision for industrial zones
Reality and vision for industrial zones
BUSINESSicon  02/08/2020 

The media have recently featured industrial properties, especially industrial land, as a potential area to attract investment.

Vietnam to develop night-time economy
Vietnam to develop night-time economy
BUSINESSicon  02/08/2020 

Prime Minister Nguyen Xuan Phuc has approved a project to develop the night-time economy in Viet Nam to allow some activities to run overnight until 6am of the next day in some major tourism cities and zones.

Transport service operators begin installing yellow number plates from today
Transport service operators begin installing yellow number plates from today
BUSINESSicon  02/08/2020 

Vehicles that have registered for transport services have started installing yellow number plates with black letters and numbers from today, August 1, instead of the current white plates.

Vietnam needs full market economy: experts
Vietnam needs full market economy: experts
BUSINESSicon  02/08/2020 

 Economists have said Viet Nam would gain many benefits from a full and modern market economy.

Business plans thrown into turmoil amid COVID-19 spike
Business plans thrown into turmoil amid COVID-19 spike
BUSINESSicon  01/08/2020 

Dang Thanh Nga, 40, in Ha Noi called 10 sewers back to work for her garment factory just a few days ago as orders increased last week. 

Mobile World tries different development models, closes some chains
Mobile World tries different development models, closes some chains
BUSINESSicon  01/08/2020 

The Gioi Di Dong (Mobile World) has seen its key brands such as The Gioi Di Dong, Dien May Xanh and Bach Hoa Xanh growing rapidly, but has also had to shut down ineffective business chains.

Startups in HR receive millions in funding despite Covid-19
Startups in HR receive millions in funding despite Covid-19
BUSINESSicon  01/08/2020 

Nearly all businesses are experiencing hardships because of Covid-19. However, this hasn't happened with startups in the HR industry. They are still receiving millions of dollars worth of funding.

Handicrafts find it difficult to catch EVFTA train to $100 billion market
Handicrafts find it difficult to catch EVFTA train to $100 billion market
BUSINESSicon  02/08/2020 

 The EU-Vietnam FTA (EVFTA) is expected to bring more opportunities to Vietnam’s enterprises to export products to the EU. However, it will be not easy for handicraft producers to obtain bigger market share there.

Vietnam to pilot night-time economic activities in 10 major cities
Vietnam to pilot night-time economic activities in 10 major cities
BUSINESSicon  31/07/2020 

The Government has approved a project on night-time economy development in Vietnam which will allow major cities and tourist attractions to pilot night-time services until 6 a.m.

Border trade rules to be tightened
Border trade rules to be tightened
BUSINESSicon  01/08/2020 

Tran Quoc Toan, Deputy Director-General of the Import-Export Department, Ministry of Industry of Trade, talks on Vietnam’s decision to gradually eliminate all temporary import and re-export activities through Vietnam-China sub-border gates.

Businesses endeavour to retain employees
Businesses endeavour to retain employees
BUSINESSicon  31/07/2020 

More than 7.8 million workers lost their jobs in the first half of 2020, putting severe pressure on labour authorities to tackle social security issues.

Booming gold market risky for individual investors: experts
Booming gold market risky for individual investors: experts
BUSINESSicon  31/07/2020 

The recent surge of gold prices may cause risks for individual buyers, experts and analysts have warned.

Vietnam to post world’s fifth-highest economic growth: WB
Vietnam to post world’s fifth-highest economic growth: WB
BUSINESSicon  31/07/2020 

Vietnam is projected to be the fifth highest-growing economy in the world this year and the country has a unique opportunity to increase its footprint in the global economy in both trade and investment, 

Pharma firms uphold fair price mechanisms
Pharma firms uphold fair price mechanisms
BUSINESSicon  31/07/2020 

Amid Vietnam’s upcoming new rules on drug tenders, multinational pharma giants are advocating price negotiation for an open business environment and predictable policies, in order to make sustainable future investments.

Vietnamese goods face tough road to foreign markets due to trade remedies
Vietnamese goods face tough road to foreign markets due to trade remedies
BUSINESSicon  31/07/2020 

With an array of free trade agreements (FTAs) inked and coming into force, countries around the world have also increased technical barriers to protect their domestic industries,

Block 114 – bright spot in offshore exploration
Block 114 – bright spot in offshore exploration
BUSINESSicon  31/07/2020 

Block 114 is located in Song Hong Basin, offshore Vietnam’s northern continental shelf, about 65km from Quang Tri province, and 86km from Da Nang city in the central region.

Vietnam gains $6.5 billion trade surplus in 7 months
Vietnam gains $6.5 billion trade surplus in 7 months
BUSINESSicon  31/07/2020 

Vietnam achieved a trade surplus of $6.5 billion in the first seven months of this year, including $1 billion in July, according to the General Statistics Office (GSO).

M&A activity expected to set new records in post-COVID period
M&A activity expected to set new records in post-COVID period
BUSINESSicon  31/07/2020 

Analysts believe that new records in the number and value of M&A deals will be set in the post-Covid-19 period.

EVFTA, Covid-19 change the face of VN logistics industry
EVFTA, Covid-19 change the face of VN logistics industry
BUSINESSicon  02/08/2020 

Vietnam’s logistics market has great opportunities to improve as the EVFTA has been inked and the country is receiving investment inflow from Europe.

 
 
 
Leave your comment on an article

OR QUICK LOGIN