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Recently, the Ministry of Health (MoH) in Malaysia introduced the National Generic Medicines Framework which aims to foster healthy competition in medicines pricing and achieve generic prescribing in both public and private healthcare institutions.

This framework is part of the country's broader effort to improve access to affordable and quality medicines by promoting the utilization of generics across the healthcare system.

Understanding Generic Medicines 

Generic Medicine is defined as a product that is essentially similar to a currently registered product in Malaysia. Generic medicines may be further classified into two groups; Scheduled Poisons and Non-Scheduled Poisons. However, the term generic is not applicable to Biologics (including biosimilars). Therefore, the scope of this framework focuses on generic medicines and does not include biosimilars.

Overview of Malaysia's Healthcare System 

Malaysia operates a dual-tiered healthcare system, consisting of a government-subsidized public sector and a private sector funded by out-of-pocket payments or insurance. In alignment with the National Medicines Policy, the framework contributes to improved health outcomes by promoting better access to essential medicines through increased use of generics.

Highlights of the Generic Medicines Framework 

  • Promotion of Generics: The framework supports generic medicines as a means to enhance competition and reduce healthcare costs.
  • Awareness Campaigns: Initiatives like the Generic Medicines Awareness Programme (GMAP) help improve understanding and acceptance of generics among both healthcare professionals and the public.
  • Patient Involvement: It encourages shared decision-making, allowing patients to choose between branded and generic medicines in consultation with healthcare providers.
  • Boosting Local Manufacturing: The framework emphasizes strengthening local manufacturing capabilities to reduce dependency on imported pharmaceuticals and ensure a steady supply of affordable generics.
  • Implementation Strategy: Key recommendations include:
    • Promoting the use of generic terminologies
    • Conducting regular medication reviews
    • Enhancing local manufacturing capacities

Keywords and Regulatory Considerations 

The framework includes regulatory aspects such as Bioequivalence (BE), Active Pharmaceutical Ingredients (API), International Non-Proprietary Name (INN) usage, product registration, and drug labelling—all crucial for ensuring the safety, efficacy, and quality of generic medicines in the market.

Conclusion 

The National Generic Medicines Framework is a vital step towards making healthcare more affordable and accessible in Malaysia. By encouraging the use of generics, strengthening local production, and promoting informed patient choices, the framework supports sustainable healthcare growth.

For pharmaceutical companies aiming to navigate Malaysia’s regulatory landscape and accelerate generic product registrations, Freyr offers end-to-end regulatory support and local expertise.

Contact Freyr today to explore how we can assist with your generic medicine strategy and regulatory submissions in Malaysia.