1. Introduction

Regulation 2, Control of Drugs and Cosmetics Regulations 1984 defines a “product” as:

1. A drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medical purpose; or
2. A drug to be used as an ingredient of a preparation for a medicinal purpose4

(For the definition of ‘medicinal purpose’ : Please refer to the Sale of Drugs Act 1952 – Section 2. Interpretation – medicinal purpose)

The products that are registered in Malaysia are approved by the Drug Control Authority (DCA) for the purpose to be sold or used in Malaysia. These products have been evaluated and tested in terms of the quality and safety of the product.

Each registered product has a registration number which is printed on the product label and/or on the product packaging1. The product registration number will start with ‘MAL’ followed by an 8 digit numbers and lastly the category of the product. Example: MAL19976399X, MAL15065021NCR, MAL14035062TS and others.

(A: prescription product, X: non-prescription product, N: health supplement, T: traditional, H: veterinary)
(C: contract manufacturer, R: repacker, S: second source, E: product for export only, Z: zero-rated GST)

Types of drug product required to be registered in Malaysia

Examples of the types of drug products required to be registered with DCA are;

1. Pharmaceutical products containing scheduled poison*l
2. Pharmaceutical products containing non-scheduled poison

   Including:

   1. Plaster containing medicine
   2. Antiseptic / Disinfectant for the use on human skin
   3. Diagnostic agent for the use in human (in vivo)
   4. Health supplement for example; Probiotic, Chitosan
3. Natural products (Herbal / Traditional)

   Including:

   1. Homeophathic medicine
   2. Ayurvedic medicine
   3. Medicated plaster
   4. Herbal Tea
   5. Health supplement for example; Spirulina, Chlorella, Royal Jelly, Bee Pollen and others.
4. Veterinary Products

   Including;

   1. Granule
   2. Paste
   3. Water soluble powder
   4. Injectable
   5. Powder for injection
   6. Oral powders
   7. Capsule / Tablet
   8. Topical ophtalmic and otic products

* Scheduled poison : Please refer to the Schedule Poison List, which is available online via http://pharmacy.moh.gov.my / Profil/ Akta & Polisi / Akta Racun 1952 / Lampiran Senarai Racun.

Regulatory body responsible to register drug products

The National Pharmaceutical Regulatory Agency (NPRA) is a regulatory body which is responsible to register drug products in Malaysia..

2. Criteria for registration of drug products

Products to be registered in Malaysia must fulfil the registration requirements determined by the Drug Control Authority (DCA), especially from the aspect of safety, quality and efficacy of the product.

Other criteria that will be taken into consideration are:

1. The need for the products, the potential of abuse, the amount of registered products, dosage form and others.
2. Therapeutic effect.

3. Drug registration process in Malaysia and registration requirements in general

The applicant for product registration is known as the Product Registration Holder (PRH) and must be from a registered company in Malaysia with the scope of business in area of health / pharmaceutical products.

If the PRH is not the product owner, the PRH will be required to obtain an Authorisation Letter from the product owner so that the PRH will be accountable for all activities involving the quality, safety and efficacy of the product. This includes activities such as updating the product information / any application sent to the NPRA.

The registration of product is via online through the QUEST system which can be assessed on the NPRA website, http://npra.moh.gov.my.

Sumber : http://npra.moh.gov.my

In general, an applicant has to register membership as a user of the QUEST system and purchase a USB Token which contains the user’s Digital Certificate before he/she can access to the system for submitting product registration. The user’s Digital Certificate is a software which can be installed into the computer of the user. This USB token can be purchased from MSC Trustgate.

There are a few packages available in which the applicant can choose to register as a user of the QUEST system. Any further inquiries can be directed to the MSC Trustgate helpline at 03-83181800.

Pemohon perlu bertanggungjawab atas sebarang aktiviti pemalsuan atau salah guna Token USB yang dimilikinya. NPRA mempunyai hak untuk meluluskan atau menolak permohonan keahlian sistem QUEST3.

The applicant is liable for any forgery activities or misused of the USB Token. NPRA has the right to approve or reject any application received for the QUEST system membership.

After the applicant has received the user ID and password from NPRA (through email), the applicant may proceed with the product registration application. The applicant also can use the online system for product registration renewal and licensing applications.

Summary of product registration procedure:

1. Visit the National Pharmaceutical Regulatory Agency website (http://npra.moh.gov.my)
2. Register as QUEST member (for first time user)

   Requirements :

   1. Company registration form
   2. Letter of Authorisation from company
   3. Copy of identity card
3. After the payment has been made to MSC Trustgate, the user Digital Certificate will be sent by MSC Trustgate to the applicant through POSLAJU in 7 working days (depending on area). The user ID and password will be emailed to the email address given during the QUEST membership registration.
4. Log-on into the QUEST system with the user ID and password and click on the ‘registration’ link and start the product registration application online. All the product registration application forms can be found in the ‘Form Tray’.
5. Submit all the data required. Applicant can refer to the Drug Registration Guidance Document (DRGD) regarding the data requirement sorted according to the product category for registering a product.
6. Provide feedback to the NPRA product evaluation officer if there are extra data needed.
7. Product will be tabled in the Drug Control Authority (DCA) meeting.
8. The product registration number will be generated if the product tabled is approved for registration.

4. Contact NPRA

Please contact Helpdesk 03-7883 5560/ 5561/ 5562 for further information regarding the QUEST system, product registration and cosmetic notification2.

References

1. National Pharmaceutical Regulatory Agency (NPRA)/ FAQ/ Product Registration http://npra.moh.gov.my/index.php/faq/product-registration. 23 Mei 2016, 1700.
2. National Pharmaceutical Regulatory Agency (NPRA)/ Contact Us/ Phone Directory http://npra.moh.gov.my/index.php/contact-us/phone-directory. 23 Mei 2016, 1730.
3. National Pharmaceutical Regulatory Agency (NPRA)/ Guidelines Central/ DRGD http://npra.moh.gov.my/index.php/guidelines-central. 23 Mei 2016, 2126.
4. Bahagian Perkhidmatan Farmasi/ Profil/ Akta & Polisi/ Akta Jualan Dadah 1952 dan Peraturan-peraturannya. http://www.pharmacy.gov.my/v2/ms/dokumen/akta-jualan-dadah-1952-peraturan-peraturannya.html. 24 Mei 2016, 1330.