The healthcare industry in Malaysia is currently valued at around $1 billion and growing at a steady rate of 6-8 percent annually. The country still imports more than half of its pharmaceuticals and medical equipment, with the U.S., Japan and Germany as its largest importers. The Malaysian government considers the country’s healthcare industry as one of its top priorities, and continually strives to implement new schemes to help boost the country’s medical sector.
Malaysia pharmaceutical registration and other regulations are carried out by the Drug Control Authority (DCA) in Malaysia, under the Control of Drugs and Cosmetics Regulations 1984. The DCA is managed by the Director General of Health, Director of Pharmaceutical Services, Director of the National Pharmaceutical Control Laboratory, and seven other appointed members. The main responsibility of the DCA is to ensure the safety, quality and efficacy of pharmaceuticals in Malaysia. Some of the DCA’s duties include (1) reviewing registration applications for drugs and cosmetics, (2) licensing importers, manufacturers and wholesalers, (3) post-marketing safety surveillance, and (4) adverse drug reaction (ADR) monitoring.
According to the DCA, any drug in a pharmaceutical dosage form, intended to be used, or capable or purported or claimed to be capable of being used on humans or any animals, whether internally or externally, for a medicinal purpose is required to be registered with the DCA. This includes products which alleviate, treat or cure diseases, products that diagnose a disease, anesthetics, and products that maintain, modify, prevent, restore or interfere with normal physiological functions. Malaysia’s pharmaceutical regulations does not apply to diagnostic agents and test kits for laboratory use; non-medicated medical and contraceptive devices; non-medicated bandages and surgical dressings; and instruments, apparatus, syringes, needles, sutures and catheters.
Drug Approval Process
Marketing Authorization Holder
In Malaysia, only local distribution companies can submit a drug registration application. Therefore, foreign companies with no local presence in Malaysia must designate a Marketing Authorization Holder (MAH) as their local representative. A MAH is responsible for submitting the product application, as well as ensuring the quality, safety and efficacy of the product.
Companies wishing to change their MAH may do so through a transfer application process. The new MAH is responsible for submitting the transfer application. But, before applying for a MAH transfer, several conditions must be met. First, according to Malaysia’s pharmaceutical regulations, no other changes may be included in the MAH transfer application, such as a change in labeling or technical data; only the MAH name and address can be changed. Second, the current product registration should be valid for at least six more months. If the license is due to expire in less than six months, the current MAH should renew the registration first, prior to the transfer.
The following documents are required for a MAH transfer application: (1) transfer application form, either submitted as a hard copy or online; (2) confirmation letter or agreement between the current MAH, new MAH and product owner, stating that all three parties agree to the transfer; and (3) a nonrefundable application processing fee. Once the application is approved by the DCA, the new MAH license will be valid for the time remaining on the previous MAH license. The product registration number will remain unchanged.
Drug Application Process
Malaysia pharmaceutical regulations include three types of applications for drug approval: (1) application for an innovator product, (2) application for a generic drug, and (3) abridged application. An application for an innovator drug includes drugs containing a new chemical or biological entity, or a new combination of existing chemicals/biologicals. Changes in product composition or characteristics (such as color, shade, flavor, fragrance or shape) will also require a new registration application. Conversely, a change in product name, specifications, packaging, indications, labeling, package insert, product literature, or excipients only requires an abridged application, which must be submitted to the DCA prior to making the change(s). (Any products imported for the purpose of clinical trials are not required to be registered with the DCA, but should have a clinical trial license. If a product will be manufactured locally for a clinical trial, a clinical trial exemption should be obtained from the DCA.)
The product registration procedure can be completed online via www.bpfk.gov.my. All product registration applications should include the following documents and information:
- Letter of authorization from the product owner; this letter should be composed on the product owner’s letterhead and be dated and signed by the Managing Director/President of the company.
- If the product is contract manufactured, a letter of authorization from the contract manufacturer (and any sub-contractors) is required; the letter should state the product name, manufacturer’s name and manufacturer’s address.
Product registration for imported products will require additional documents and information, including:
- Certificate of Pharmaceutical Product (CPP) from the pharmaceutical authority in the country of origin. (If a CPP is not available, a GMP certificate or manufacturing license is generally acceptable along with either a (1) CPP from the country of the product owner or (2) CPP from country of release.)
- Alternatively, traditional medicines, dietary supplements, and external personal care products require a Free Sale Certificate and Good Manufacturing Practice (GMP) certificate.
A separate application is required for each product to be registered. Products with the same ingredients but different specifications, such as the amount of ingredient(s), dosage forms, descriptions, manufacturer, etc., will require a separate application for each product registration. Products differing only in their packaging materials or pack sizes can be registered in a single product application.
Application Review and Timeframe
The DCA’s application review process follows a queue system, which is divided by product type: New Chemical Entity (NCE), biotechnology products, generic products, abridged applications and traditional products. However, if a product is used to treat a serious or life-threatening disease, the DCA may expedite the review process for that particular product.
Once a product application has been submitted to the DCA, the DCA may require clarification or additional information. In this case, the applicant will have four months to collect and submit this information. If the applicant exceeds this four month period, the application review process can be terminated due to Malaysia pharmaceutical regulations. The applicant will have to submit a new application and start from the beginning of the application process.
Once the application review process is complete, the DCA will notify the MAH of its decision via e-mail. When a product is approved, the DCA will assign a registration number to the product, which is associated with the product’s name, composition, characteristics, origin, manufacturer and MAH. The registration number cannot be used with any other product. Product registration is valid for five years; renewal applications should be submitted approximately six months prior to the expiration date of the registration.
If the DCA does not approve a product, the applicant has the option of submitting a written appeal within fourteen days from the date of the DCA’s announcement. If the appeal is accepted, the applicant will be able to submit additional documentation to support the product application. The grace period for NCE and biotechnology products is 180 days; all other types of products will be granted a 90-day grace period. It is unlikely for the DCA to grant extensions beyond the 90- or 180-day grace periods.
Safety and Post-Marketing Surveillance
Adverse Effect Reporting
In Malaysia, ADRs are handled by the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) under the DCA. MAHs are required to report any adverse effects to the MADRAC, though healthcare professionals are also encouraged to submit ADR reports as well.
The DCA has the right, by Malaysia pharmaceutical regulations, to test products for compliance with official pharmaceutical standards in Malaysia or with specifications set by the product manufacturer. If the product tested does not meet the specifications, a warning will be issued to the MAH. The MAH will have 30 days to address and correct the problem. If a product recall is necessary, the MAH is responsible for notifying the DCA prior to the recall.
A licensed manufacturer of pharmaceuticals in Malaysia is responsible for meeting the DCA’s manufacturing, processing, packing and labeling standards, and should conduct regular inspections to ensure the quality and safety of the products. A manufacturer should ensure that all equipment is in good working condition and regularly calibrated, and regularly check and clean all manufacturing equipment. Manufacturers should keep records of each batch of finished products that are distributed in Malaysia. This will allow for a prompt product recall, if necessary.
Inspections of a manufacturing site may occur at any time, and can involve the inspection of the premises, operations occurring on the premises, a particular product, or the inspection of a registration license.
Wholesalers and Importers
Licensed wholesalers and importers in Malaysia should maintain records of every transaction involving a registered pharmaceutical product. The records should be kept for at least five years from the date of the transaction. Licensed wholesalers are responsible for keeping records with the following information: (1) date of sale, (2) name and address of the purchaser, (3) name and quantity of the product sold, (4) product registration number, and (5) number of the invoice or delivery order. Likewise, importers in Malaysia are responsible for keeping records with the following: (1) date of importation, (2) name and address of the supplier, (3) name and quantity of the imported product, (4) number of the bill of lading, (5) date of the sale, and (6) name and address of the purchaser.
Promotion and Advertisement
The Pharmaceutical Association of Malaysia (PhAMA), an industry trade body, has been granted permission by the Ministry of Health (MOH) to regulate pharmaceutical sampling in Malaysia. PhAMA’s guideline, The Code of Conduct for Prescription (Ethical) Products, outlines the Malaysia pharmaceutical regulations for sampling.
According to the Code, pharmaceutical samples can only be distributed to a doctor, or someone authorized by a doctor to receive samples on the doctor’s behalf. Any companies distributing pharmaceutical samples to doctors in Malaysia are required to keep careful records of which doctors have been sent samples. Oftentimes, international companies will ask the doctor to sign a receipt upon receiving the sample. However, samples may not be used as an incentive to encourage doctors to purchase a specific product.
All samples must be labeled on the outer pack with sample not for sale. Additionally, the outer pack should contain the following information in English (and other language(s), if desired): Malaysian registration number, name of the company that owns the registration, name of the importer, name of the distribution company, batch number and expiration date.
Pharmaceutical promotional materials are also regulated by the Code of Conduct for Prescription (Ethical) Products. Under the guideline, only members of the medical profession can receive promotional material for prescription drugs. Pharmaceutical companies are not permitted to advertise prescription products directly to the Malaysian public, though direct advertising of OTC products is permitted.
Specifically, the Code outlines the requirements and restrictions for pharmaceutical advertisements. The promotional material must include information about product side effects and any claims made by the company should be supported by clinical data.
Pharmaceutical Labeling Update
Due to the government’s concern with counterfeit and unregistered pharmaceuticals in Malaysia, the MOH issued the Directive on the Use of the Hologram Security Device. This directive will affect Malaysia pharmaceutical regulations by eventually requiring that all pharmaceuticals, including health supplements, traditional products and OTC external personal care products to bear a hologram security label, called a Meditag. The label will have a unique serial number, which verifies that the product has been registered with the DCA; the label can be traced to the licensed manufacturer or importer of the product. This new requirement was implemented in two phases. Phase I began on January 1, 2005 and required non-parenteral products (non-injections) to be labeled with a hologram. Phase II started on July 1, 2005, and requires hologram labeling for injectable pharmaceuticals. Temperature-sensitive products that require cold chain maintenance, such as vaccines and biologicals, will not require a hologram. Additionally, cosmetics will also be exempt from hologram labeling.
The hologram, which is approximately 8mm x 16mm, should be placed on the front panel of the product label on the outer packaging of the product. Each unit of sale requires a hologram; the customer should be able to see the hologram without opening the box/container. The local manufacturer (or the re-packer in the case of products that are imported to Malaysia and packed locally) or the importer is responsible for affixing the hologram label to the products. However, the labels may also be sent to the overseas manufacturer of the product, affixed overseas, and then imported pre-labeled.
Only one hologram manufacturer is authorized to sell, distribute and keep record of the holograms provided—Mediharta Sdn Bhd. Each label costs RM0.056 (US 1.5 cents). A minimum order of one roll (15,000 labels) or two sheets (100 labels per sheet) is required.
Companies who still have products on the shelves without an affixed hologram will not be required to conduct a recall. It is simply up to the customers to decide whether they feel comfortable purchasing products without a hologram. However, if a manufacturer or importer does not show any attempt to meet the hologram labeling requirements, the MOH can suspend the product registration until the manufacturer or importer complies with the new Malaysia pharmaceutical regulations.
Malaysia does not currently have a medical device regulatory authority, though a draft Medical Device Act is currently under review. The regulation is not expected to be passed for at least another year, but when effective, is expected to establish medical device standards, including (1) the adoption of some international technical standards, (2) labeling requirements, (3) specific requirements for sterilization, toxicological testing and clinical evaluation, (4) pre-market evaluation of high-risk devices, (5) post-marketing surveillance of adverse incidents, and (6) a quality management system. Presently, medical devices in Malaysia only require paperwork for such activities as the collection of payments, delivery of stock, etc.
In Malaysia, cosmetics are regulated by the DCA. The DCA is responsible for the following activities: (1) the safety, quality and performance of cosmetics; (2) providing consumers with adequate information in order to choose the best product for themselves; and (3) monitor all cosmetic products from the manufacturing process to the marketplace. The regulatory environment for cosmetics is defined under the Control of Drugs and Cosmetic Regulations. This regulation provides specifications for manufacturing, labeling, distribution and sales. Any manufacturers, importers or wholesalers of cosmetics in Malaysia must be licensed by the DCA.
The Control of Drugs and Cosmetic Regulations defines cosmetics as any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition .
Cosmetic manufacturers in Malaysia should meet Good Manufacturing (GMP) guidelines and are required to list all ingredients on the product label. The ingredients should be listed according to their International Nomenclature Cosmetic Ingredient (INCI) names.
The DCA has also established an enforcement program to ensure that cosmetic product manufacturers comply with cosmetic regulations. As part of the program, the DCA can send out representatives to randomly gather cosmetic products available on the market in Malaysia. These products may be tested to ensure product safety and quality.