AMENDED PHARMACY LAW MUST SUPPORT FOREIGN ENTERPRISES IN VIETNAM

The amended Law on Pharmacy is key in ensuring comprehensive and adequate healthcare resources for the people.

HÀ NỘI — Deputy Prime Minister Trần Hồng Hà emphasised that the amended Law on Pharmacy must include regulations to support foreign pharmaceutical enterprises to invest in drug production and technology transfer in Vietnam.

Speaking at a meeting on February 19 to discuss the law on amendments and supplementations to some articles of the Law on Pharmacy, Deputy PM Hà said the pharmaceutical industry management and development face many difficulties and shortcomings.

Therefore, the amended Law on Pharmacy is key in ensuring comprehensive and adequate healthcare resources for the people.

Ha asked the Ministry of Health (MoH) to collect ideas and fully clarify regulations in the bill, especially those related to the implementation of international commitments and agreements, as well as laws on investment, price management, advertising and rights of foreign-invested enterprises.

At the same time, the simplification of administrative procedures in the field should ensure close, scientific management and safety, he said.

The leader also asked the MoH to support foreign pharmaceutical firms to invest in drug production and transfer technologies in Vietnam, and effectively tap domestic herbal medicine potential.

Resolving difficulties

According to the MoH, the law aims to resolve difficulties and obstacles in legal framework related to drug management activities, including ensuring effective prevention and control of diseases and emergency cases arising in practice. It also aims to continue administrative procedure reforms in pharmaceutical management activities, ensuring enhanced accessibility to medicines for people and businesses.

The law focuses on developing the pharmaceutical industry; reorganising the drug distribution and business system, drug registration, circulation of drugs, and raw materials for drug production; supplementing the application of principles and good manufacturing practices (GMP) standards for drug production; and managing import-export activities, drug advertising information, raw materials for drug production, and price regulation of drugs, it said.

In particular, the drafting committee has identified and designed amendments to maximise access to international norms in State management of drug production, business and distribution.

According to Deputy Minister of Health Đỗ Xuân Tuyên, three key pillars in the management of the pharmaceutical industry are management of drug circulation registration, prices, and quality of drugs.

At the meeting, participants presented ideas on various issues included in the bill.

Senior Lieutenant General Nguyễn Duy Ngọc, deputy minister of Public Security, proposed appropriate management measures for toxic medicinal herbs used in pharmaceutical production, while ensuring a certain level of openness in importing medicine in urgent situations to serve national defence and security needs.

Deputy Minister of Justice Đặng Hoàng Oanh proposed that the bill specify regulations on supporting and promoting the growth of the pharmaceutical industry.

Regarding the rights and responsibilities of foreign-invested pharmaceutical firms in drug distribution, Deputy Minister of Planning and Investment Nguyễn Thị Bích Ngọc said the MoH should design regulations consistent with World Trade Organisation (WTO) definitions, current laws, and compatible with other industries.

Deputy Minister of Justice Oanh added that the drafting committee needs to review and evaluate the regulations on the rights and responsibilities of foreign-invested pharmaceutical businesses in logistics activities with international commitments and Vietnamese laws.

Pfizer Vietnam General Director Darrell Oh proposed the application of mechanisms to use assessment and inspection results of pharmaceutical management agencies recommended by WHO, aiming to reduce the overload situation in drug registration licensing.

In response to these opinions, Minister of Health Đào Hồng Lan affirmed that the bill has simplified procedures, shortened the time for drug circulation registration from three months to 15 days, and implemented automatic extension forms.

Under market rules

Speaking at the meeting, Deputy PM Hà requested the MoH study and provide comprehensive explanations for the provisions in the law related to fulfilling international commitments, specialised laws regarding investment, price management, advertising and the rights of foreign-invested enterprises.

He urged the MoH to establish regulations on the recognition, acknowledgment, referencing of standards, and quality of drugs that have been inspected by the WHO or national drug regulatory agencies recommended by the WHO.

At the same time, it should supplement some clinical pharmacological assessment criteria for evaluating drugs to ensure safety and suitability for Vietnamese people’s physiology.

The Deputy PM stressed the need to manage the pharmaceutical industry under market rules, ensuring publicity, transparency, quality control, safety and lowest prices for the ultimate goal of ensuring that people have access to the best, safest and most affordable drugs. — VNS

Source: Việt Nam News

About STELLAPHARM

Stellapharm is one of leading generics pharmaceutical companies and strong producer of anti-viral drugs in Vietnam. The company established in Vietnam in 2000; and focuses on both prescription drugs and non-prescription especially in cardiovascular diseases, antiviral drugs, anti-diabetics drugs, etc. and our products are now used by millions of patients in more than 50 countries worldwide.

The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

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