Calls for draft decree on pharmacy law amendments to make it easier for business

Calls for draft decree on pharmacy law amendments to make it easier for business

The pharmaceutical industry is key and needs to focus resources on promoting development to keep pace with modern medical advances.

Packaging vaccine products at a factory in Hưng Yên Province. — VNA/VNS Photo Vũ Sinh

Pharmaceutical enterprises and industry associations voiced their opinions on the draft decree guiding amendments and supplements to the pharmacy law during a recent conference in Hà Nội.

Nguyễn Lan Hương from Sanofi Vietnam JSC emphasised the need to review regulations on managing drug imports, without a circulation registration certificate in Việt Nam.

Hương suggested that drugs containing pharmaceutical substances without a circulation registration certificate, as well as imported rare drugs, should only be supplied to medical examination, treatment centres and vaccination facilities.

Pharmacist Nguyễn Thị Hồng Vân, a representative of Sao Thái Dương JSC emphasised the importance of the research, production, registration and advertising of drugs using cell and gene technology.

She said regulatory agencies in the US and Europe, as well as some in Southeast Asia, such as Singapore and Malaysia, have implemented specific guidelines for the research, clinical trials and licensing of these innovative therapies.

Vân called on regulatory guidelines to support the development of medical products derived from cell and gene therapy, stem cells and exosomes in Việt Nam.

According to Vân, the demand for these advanced medical treatments is significant, with many Vietnamese patients travelling abroad to access such therapies.

Meanwhile, both domestic and international investors, researchers and manufacturers are eager to develop these products within Việt Nam. However, the lack of specific regulations in pharmaceutical management has posed challenges for research, production, import-export, and commercialisation.

Vân stressed the necessity of establishing a clear legal framework to facilitate the research, development, production, distribution and promotion of cell and gene technology-based drugs, ensuring their effective application in the country’s healthcare sector.

A representative of Traphaco JSC proposed simplifying customs procedures for the import and export of drugs and pharmaceutical ingredients. The representative suggested removing the requirement to present original or certified copies of specialised documents during customs clearance.

For example, requiring the presentation of the original test certificate would take a lot of time for businesses to request manufacturers to do it specifically for the Vietnamese market.

In addition, sending this certificate would also delay the customs clearance of goods, incur storage costs and slow down the production progress of businesses, the representative said. 

The law on amendments and supplements to a number of articles of the Law on Pharmacy takes effect from July 1, 2025. It includes new regulations on State pharmaceutical policies and pharmaceutical industry development, diversification of the systems and methods for trading and distribution of drugs and medicinal ingredients.

It also regulates the reduction and simplification of business conditions and administrative procedures, decentralisation enhancement and the management of export and import of drugs and medicinal ingredients in accordance with current development and international practices.

The pharmaceutical industry, is a key industry and needs to focus resources on promoting development, experts have said. 

On October 9, 2023, the Prime Minister signed Decision No 1165/QĐ-TTg, approving the national strategy for developing Việt Nam's pharmaceutical industry for the period to 2030 and vision to 2045 to develop the domestic pharmaceutical industry on par with advanced countries in the region, ensuring people have access to medicine at a reasonable cost. 

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