Market Approval Process for Generic Drugs in Brunei

The APAC market for generic drugs is forecasted to grow US 112.86 USD billion by 2025 from 75 billion in 2020 with a CAGR of 8.34% from 2020 to 2025. There is a growing demand for generic drugs in regions like Vietnam, Myanmar, Philippines, Laos, Brunei, etc.

The generic drug registration in these regions is simple but obtaining a clear regulatory process is difficult due to language barriers.

Due to increased demands for registering drugs in these regions, we have seen a steep rise in requests for knowing the regulatory, requirements, and registration service.

To register your generic drug in Brunei you need to know 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 the generic drug registration?
  • What is the post-approval process such as importation and license? and much more

To handle requests for knowing the regulations and requirements for registering generic drugs in Brunei we have created a report answering all the questions mentioned above, which describes the complete generic drug regulatory scenario in Brunei.

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

Due to the increase in interest of the manufacturers to market their generic drugs in Brunei, we are receiving an increased number of queries. We found that some of the queries were to understand the regulatory and process feasibility as the information available is not clear or incomplete.

Credevo has prepared a 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.

What would you get by downloading this report?

  1. Details on the regulations, requirements, and process to register the generic drugs in Brunei.
  2. Free assessment by Credevo to review your generic products and available data to know the applicable regulations.

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 Brunei 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.

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