Pharma Expansion and Strategic Entry: Mastering the Art of Generic Drug Registration in Vietnam"
Anum Mukhtar
|Global Regulatory Affairs Consultant| Regulatory Intelligence |Artificial Intelligence| ANDA CMC Pharmaceutical| Nutraceuticals| OTC| Cosmetics| Food Supplements| Business Development | RAPS| Managing Projects & teams|
Introduction:
The pharmaceutical market in Vietnam is experiencing robust growth, with a projected increase of 5.47% from 2024 to 2028. As a major market for generic drugs, Vietnam offers significant opportunities for foreign pharmaceutical companies. This blog aims to provide valuable insights into the regulatory landscape, requirements, and processes for registering generic drugs and strategic entry in Vietnam, empowering manufacturers to make informed decisions.
Understanding the Vietnamese Pharmaceutical Market:
Before delving into the registration process, it's essential to grasp the dynamics of the Vietnamese pharmaceutical market. Factors such as customer preferences, market trends, and local circumstances play a crucial role in shaping the industry landscape. Vietnamese consumers are increasingly embracing modern medicine, contributing to the demand for generic drugs. Trends such as the preference for cost-effective generic alternatives and the growth of the over-the-counter (OTC) market highlight market opportunities for foreign manufacturers.
Economic overview:
Economic growth and demographic changes are driving demand for healthcare services throughout Vietnam, and not just in the two economic centers of Hanoi and Ho Chi Minh City. Public, provincial-level hospitals funded by the government are undergoing upgrades of their facilities and opening new departments for specialty treatment. Such developments are creating new opportunities for medical device companies in Vietnam.
The Vietnamese government has identified the pharmaceutical industry as a potential key driver of future economic growth and prosperity in its “National Master Plan for the Vietnamese Pharmaceutical Industry Development to 2020 with a Vision to 2030” (“Master Plan”).
Key focus areas under the Master Plan include:
Regulatory Authority and Submission Process:
In Vietnam, the regulatory authority responsible for evaluating pharmaceutical registrations is the Ministry of Health. To initiate the generic drug registration process, an authorized representative, holding the product license, must submit the application. For foreign manufacturers, the applicant should be a resident representative with an authorization letter from the overseas manufacturer to the local party.
Bioequivalence Studies and Documentation:
Bioequivalence studies are a crucial component of generic drug registration in Vietnam. However, the acceptance of foreign bioequivalence data may vary and requires evaluation by the regulatory authority. The submission process involves providing a comprehensive drug dossier with detailed information on quality, safety, and efficacy. Compliance with Good Manufacturing Practices (GMP) guidelines is mandatory.
Additional Requirements and Considerations:
Manufacturing site accreditation, stability studies, and adherence to labeling compliance are vital elements of the registration process. The timeline and costs associated with generic drug registration in Vietnam may vary, contingent on the complexity of the drug and the efficiency of the regulatory authority. Collaboration with local consultants or regulatory affairs experts is recommended to navigate the process seamlessly.
Post-Approval Processes:
Once the generic drug receives approval, the post-approval phase involves obtaining a license to import the product into Vietnam. Compliance with import regulations, additional documentation, and adherence to specific fees are essential aspects of this stage.
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Strategic Entry:
Companies entering the Vietnamese market will need to consider two marketing strategies;
The two markets also differ in terms of consumer behavior and preferences.
To enter or expand in Vietnam, businesses may do so indirectly through the appointment of an agent or distributor. Companies new to Vietnam should conduct due diligence on potential local agents/distributors to ensure they possess the requisite permits, facilities, and human and financial resources.
Vietnam offers strong potential for the generic market due to the country’s consumer purchasing power being quite low in relation to the pricing of the patented drugs. However, there is expected to be momentum for the specialty drugs in the future as well.
Conclusion:
While the Vietnamese pharmaceutical market presents lucrative opportunities for foreign manufacturers, understanding and complying with regulatory requirements are paramount for success. The comprehensive guide addressing following questions aims to equip pharmaceutical companies with the knowledge needed to navigate the registration process in Vietnam.
What is the demography of Vietnam?
What is the regulatory authority and its framework in Vietnam responsible for registering pharmaceutical products?
What is the registration process and how can foreign pharmaceutical manufacturers register their products in Vietnam?
What are the requirements for dossier submission?
What are the life cycle management parameters?
What are the market insights will be considerable for new market entrants?
What are considerable points for market entry strategy?
What are the main competitors?
What are the opportunities, challenges and product selection prospects?
Ready to explore the Vietnamese pharmaceutical market? Request your customized Regulatory Intelligence Report today for a detailed roadmap to registering your generic drug successfully. DM for personalized guidance and insights.
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