Vietnam Pharmaceutical laws revised to support domestic CDMO’s

Leveraging the Made in Vietnam advocacy, the Vietnam Ministry of health announced the revised pharmaceutical laws in the last month of the year 2024.

Addressing the range of manufacturing processes such as high shear granulation, low shear granulation, drying, blending, Hardgel encapsulation, suppository encapsulation, compression, coating and ensuring high quality standard of products to adherence to EUGMP/FDA guidelines. The Product journey passes through a complete cycle before reaching to the consumer, so that he can avail the value at a cost-effective price. The generic pharmaceutical industry in Vietnam is continuously striving to maintain the quality of medicine.

The new amended law is ensuring adequate and timely supply of quality drugs at reasonable prices for disease prevention and treatment requirements. Another is ensuring rational, safe, and effective use of drugs, with policies to develop clinical pharmacy.

Incentives for drug purchases can apply in the following cases: drugs researched and produced domestically using domestic raw materials; original brand-name drugs with technology transfer in Vietnam; the first domestically produced generic drugs; the first domestically produced biosimilars; medicinal herbs and traditional drugs using domestic medicinal materials that meet Good Practices for Cultivation and Collection of Medicinal Herbs; medicinal herbs and traditional drugs produced on the basis of national, ministerial or provincial science and technology tasks that have been accepted; drugs on the list of national products approved by the PM of Vietnam.

Regarding preferential policies and investment support policies for the development of the pharmaceutical industry, the amended law stipulates they must be in accordance with the Law on Investment.

Regarding the issuance, renewal, change, or supplementation of marketing authorisation (MA), the National Assembly Standing Committee has revised the amended content in Article 56 by not specifically regulating in the amended law but assigning Ministry of Health to specify the necessary dossiers and procedures.

The growth of global pharmaceutical market size is reaching a value of 1.5trillion USD by the end of the forecast period between 2023 to 2027. Vietnam’s Pharmaceutical market presents a significant opportunity of growth in OTC sector due to several factors contributing to the upswing.

A rapidly aging population, along with a growing prevalence of chronic diseases has intensified the need for affordable healthcare solutions.

Rising consumer interest in self-medication and preventive healthcare practices. Demanded the initiatives to support domestic CDMO’s and asked for Government support for development of domestic pharma industry. Aiming to reduce dependency on imported medicine and promoting local production capabilities.

Taking this line of thought into practice OPV has revamped its manufacturing lines of solid, liquid and sachet lines.

Which provides comprehensive support throughout the scale-up process and validation process. OPV’s technical team ensures a seamless transition from laboratory to commercial manufacturing, whether scaling up within our facilities or undergoing a technology transfer.

At OPV CDMO, we offer cutting-edge solutions and ample capacity to support your requirements from initial development stages to full-scale commercial manufacturing. Our primary objective is to seamlessly integrate your product’s technology while prioritizing quality, efficiency, and regulatory adherence.

The processes are critical for maintaining a controlled and sterile environment necessary to produce pharmaceutical products. OPV’s CDMO strictly adheres to Good Manufacturing Practice (cGMP) standards and guidelines set by regulatory authorities such as the WHO and EUGMP. Our commitment to maintaining a controlled manufacturing environment ensures that products meet the highest quality standards throughout the manufacturing process.

With these positive changes, the amended law is expected to create more favorable conditions for the business community in the Vietnam pharmaceutical industry.

The amended law will take effect from July 1, 2025, except for the regulation on renewal of MA of drugs and pharmaceutical ingredients, which will take effect from January 1, 2025.

OPV wishes all A Happy & Prosperous 2025.

Source of MOH article: https://vir.com.vn/potential-fie-impacts-through-law-on-pharmacy-adjustments-112574.html