Market Approval Process for Generic Drugs in Brunei

Market Approval Process for Generic Drugs in Brunei

The Asia-Pacific region is emerging as a new destination for generic drugs. The Asia-pacific market is forecasted to grow from USD 75 billion in 2020 to USD 112 billion by 2025 at a CAGR of 8.34%. The growth of the generic drugs market is accelerated by many factors such as the aging population, increasing pharmaceutical spending towards generics, and the impending expiry of patented drugs.

The attractive pharmaceuticals market growth in ASEAN countries like Vietnam, Singapore, Indonesia, Malaysia, Philippines, Thailand, Brunei Darussalam, Laos, Myanmar, and Cambodia are becoming the market of interest for many pharmaceutical companies.

The regulatory environment among all the ASEAN countries is quite similar but still, the regulatory requirements and the process of registration significantly differ. Hence,  understanding the process of registration & regulatory requirements can be advantageous in order to register a medicinal product and enter into the market.

To register your generic drug in Brunei, you need to find answers to the following

  • Which is the regulatory authority?
  • How can foreign manufacturers register their generic drugs in Brunei?
  • How about Bioequivalence data?
  • Is the foreign bioequivalence data acceptable in Brunei?
  • What are the requirements to register your generic drug in Brunei?
  • How about the manufacturing site accreditation, or other such requirements?
  • What are the timelines and costs involved in generic drug registration?
  • What is the post-approval process such as importation and license? and much more

Get Details on Regulatory, Requirements, and Process for Registering Generic Drugs in Brunei.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering generic drugs in Brunei. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.