For drugs already approved in Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) under the Malay Ministry of Health, has set up a new pilot program where additional drug indications can be approved if such indications have been approved by certain foreign MOHs. The foreign countries that the NPRA will rely on include the US, EU, UK, Australia, Health Canada, and the Japanese PMDA. This program started on August 1 and will run for one year. Under this pilot, if the application has the requisite documents, the review for a new or additional indication will be about 90 days – less than before. Additional indications may include things like new usage in children, new routes of administration, new therapeutic areas, etc.
Under this pilot program, there are two kinds of evaluation processes including – 1. a full review or 2. A verification process. For the full review, medical specialists may be required to provide feedback, and the new indication must have been approved by at least one of the foreign reference health authorities above. In addition, the new indication approval must have occurred within 3 years of the approval in the reference country. For the verification process, no medical specialists will be needed to provide feedback but the indication approval must have been done in at least 2 of the foreign reference health authorities. Drug registration in Malaysia is done online through the Quest 3 System. Malaysia’s pharmaceutical market is growing at about 9% per year and is estimated to be around $5 billion now.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.