The Malaysia pharmaceutical market, currently valued at about $1.6 billion, is still relatively small but grown quickly. The pharmaceutical market is set to grow at about 7% between 2012 and 2014. Original branded drug sales, through retail pharmacies, comprised over 15% of the total pharmaceutical market in Malaysia in 2011. The pharmacy sector is currently valued at about $300 million with a Compound Annual Growth Rate of about 13%.
There are over 290 Malaysian pharmaceutical licensed drug manufacturers in the country. Currently, nine of the top ten manufacturers in the Malaysia pharmaceutical market are multinationals. GlaxoSmithKline and Ranbaxy are two examples of large multinational companies that have manufacturing sites in Malaysia.
The government has identified biotechnology as one of the core technologies to enhance the Malaysian economy.
Drug Regulatory System:
Pharmaceuticals are regulated by the Drug Control Authority (DCA) in Malaysia, operating under the Control of Drugs and Cosmetics Regulations Act of 1984. Under the Act, any drug intended to be used on humans, whether internally or externally, for medicinal purposes is required to be registered with the DCA. An application for registering a new product for the Malaysia pharmaceutical market can be sub-divided into one of the following:
A). Application for an innovator product: this product contains a new chemical or biological entity, a new combination of existing chemical/biological entities, or new dosage forms, that has not been registered by the DCA before and will require:
- administrative data,
- data to support product quality,
- data to support product safety, and
- data to support product efficacy.
B). Application for a generic product: this product is essentially similar to the currently registered products in Malaysia and will require:
- administrative data, and
- data to support product quality.
C). Application via the abridged procedure: this applies to certain categories of Over the Counter (OTC) drugs and traditional medicines which include skin disinfectants and topical nasal decongestants, that will only require administrative data.
Please note that the Malay DCA prefers web-based online drug submissions via the official government website. The applicant is responsible for updating any information relevant to the product or the application. The DCA should be informed in a timely manner of any change in product information during the course of evaluation and even after product registration. All applications must be accompanied by:
- a letter of authorization from the product owner (not applicable if the applicant is the product owner), and
- if the product is contract manufactured, letters of authorization from the contract manufacturer or any sub-contractors are also necessary.
Imported products will also require either a:
- Certification for Free Sale (CFS) and Good Manufacturing Practice (GMP) from relevant authorities, OR
- Certificate of Pharmaceutical Product (CPP).
Application for registration of a new product will be rejected if the applicant fails to supply all necessary documents and data within 6 months from the last correspondence date. An application will get a definitive approval or denial. The DCA decision will be sent via e-mail to the applicant.
The product registration will be valid for the Malaysian drug market for 5 years or as specified in the registration certification (unless indicated otherwise by the DCA). Product registration renewal must be completed 6 months prior to the expiration of the product registration. Product registration renewal will not be accessible upon expiry of the registration validity period.
Product Registration Transfers:
A product registration can be transferred from one product registration holder to another holder through a transfer procedure. This expedites the processing time and maintains the same product registration number. However, in order to transfer, certain conditions must be met such as:
- the new product registration holder must submit an application for permission to transfer the product registration,
- the existing product registration must have at least 6 months of validity left. If the remaining validity period is less, product registration renewal should be completed by the current holder before a transfer application can be submitted, and
- if the requirements for the transfer procedure are not met or a new product registration number is desired, then a new application should be submitted.