Indonesia’s pharmaceutical market is the largest market in the Association of Southeast Nations (ASEAN). The current pharmaceutical market is worth IDR 84 trillion (USD 6 billion) and is expected to reach $10.11 billion by 2021.
Some of the key factors for the growth of the Indonesia market include
- Growing life expectancy and increased government healthcare spending,
- Introduction of 15 economic policy packages to attract foreign investors,
- Implementation of the Universal Health Coverage scheme, and
- Growing urban population.
To register your generic drug in Indonesia, you need to know the following
- Which is the regulatory authority in Indonesia?
- How can foreign manufacturers register their generic drugs in Indonesia?
- How about Bioequivalence/Bioavailability studies?
- Is the foreign bioequivalence data acceptable in Indonesia and in which conditions the bioequivalence studies are necessary?
- What are the complete requirements to register your generic drug in Indonesia?
- How about the manufacturing site accreditation, or other such requirements for registering the generic drug?
- What are the timelines and costs involved in generic drug registration?
- What is the post-approval process such as importation and license to import?
Get details on Regulatory, Requirements, and Process for Registering Generic Drugs in Indonesia.
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