There is a growing demand for generic drugs in Malaysia. The government is the largest pharmaceutical buyer in Malaysia and is responsible for more than half of the purchasing value. The Indian, Chinese, and other similar drug manufacturers have begun playing a dominant role in the Malaysian pharmaceutical market.

In Malaysia, the pharmaceutical manufacturing sector produces exclusively generic drugs, and the sales revenues amount to only 1.5% of gross domestic product (GDP). That shows the great demand for generic medicines in Malaysia.

To register the generic drug in Malaysia, you need to know answers to the following

• Which is the regulatory authority for generic drug registration in Malaysia?
• How can foreign manufacturers register their generic drugs in Malaysia?
• How about Bioequivalence/Bioavailability study requirements in Malaysia?
• Is the foreign bioequivalence data acceptable in Malaysia and in which conditions the bioequivalence studies are necessary?
• What are the complete requirements to register your generic drug in Malaysia?
• How about the manufacturing site accreditation, or other such requirements for registering the generic drug in Malaysia?
• 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 Malaysia.

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 Malaysia. 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.