What is a registered drug?
A registered drug is a drug that is approved by the Drug Control Authority (DCA) for sale/use in Malaysia. This drug has been evaluated and tested for its efficacy and safety. Every registered drug is given a registration number, which must be printed on its label or package. These numbers start with MAL. Example of a registration number is: MAL19976399X
What needs to be registered?
a. Pharmaceutical products containing scheduled poisons.
b. Pharmaceutical products containing non-scheduled poisons (OTC)
Includes:
+ Medicated plaster with medicines
+ Antiseptic/ Disinfectants for use on the human body
+ Diagnostic agents for human use (in vivo)
+ Dietary supplement e.g. Probiotics, Chitosan
c. Traditional products
Includes:
+ Homeopathic medicines
+ Ayurvedic medicines
+ Medicated plaster
+ Herbal teas
+ Dietary supplements eg. Spirulina, Chlorella, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, Extract of chicken with herbs
d. Veterinary products
Includes:Oral solution, oral suspension, emulsion
+ Granules
+ Paste
+ Water soluble powder
+ Injectable
+ Powder for injection
+ Oral powders
+ Capsule, tablet
+ Topical ophtalmic and otic products
* Guidance Decision Tree
b. Pharmaceutical products containing non-scheduled poisons (OTC)
Includes:
+ Medicated plaster with medicines
+ Antiseptic/ Disinfectants for use on the human body
+ Diagnostic agents for human use (in vivo)
+ Dietary supplement e.g. Probiotics, Chitosan
c. Traditional products
Includes:
+ Homeopathic medicines
+ Ayurvedic medicines
+ Medicated plaster
+ Herbal teas
+ Dietary supplements eg. Spirulina, Chlorella, Royal Jelly, Bee Pollen, Aloe Vera juice, Noni juice, Extract of chicken with herbs
d. Veterinary products
Includes:Oral solution, oral suspension, emulsion
+ Granules
+ Paste
+ Water soluble powder
+ Injectable
+ Powder for injection
+ Oral powders
+ Capsule, tablet
+ Topical ophtalmic and otic products
* Guidance Decision Tree
What do not need to be registered?
a. Raw herbs, including those that are dried & cut into pieces
b. Diagnostic agents/ test kits for in vitro use - please refer to this link for more information. Diagnostic agents/ test kits for laboratory use must be labeled 'FOR LABORATORY USE ONLY'. Products which are not labeled as such shall be deemed to be for human or animal use and need to be registered with the DCA.
c. Medical devices - please refer to this link for more information.
Includes:
+ Blood bags containing anti-coagulants
+ Visco-elastic products for mechanical or physical protection of tissues during or after surgical procedures
+ Non-medicated plasters
+ Wound care/dressing materials containing hydrogel, collagen, calcium alginate
+ Disinfectants for equipments/ devices
+ Lubricants for gloves, condoms and endoscopes
+ Contact lens care products
+ Copper IUDs
+ Bone cement, tissue adhesives
e.Insect repellents
f. Body-building products containing protein/whey/ soya bean
g. Food - as defined under the Food Act 1983 and Food Regulations 1985, includes every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances. This includes food for special dietary use for persons with a specific disease, disorder or medical condition, and food which contain quantities of added nutrients allowable under the Food Act and Regulations.
* For information on Food - Drug Intephase products, please refer to subtitle 'Regulatory Information' > 'Other guidelines' > 'Classification decision tree' for further details.
h. Detergents/ disinfectants for domestic use
b. Diagnostic agents/ test kits for in vitro use - please refer to this link for more information. Diagnostic agents/ test kits for laboratory use must be labeled 'FOR LABORATORY USE ONLY'. Products which are not labeled as such shall be deemed to be for human or animal use and need to be registered with the DCA.
c. Medical devices - please refer to this link for more information.
Includes:
+ Blood bags containing anti-coagulants
+ Visco-elastic products for mechanical or physical protection of tissues during or after surgical procedures
+ Non-medicated plasters
+ Wound care/dressing materials containing hydrogel, collagen, calcium alginate
+ Disinfectants for equipments/ devices
+ Lubricants for gloves, condoms and endoscopes
+ Contact lens care products
+ Copper IUDs
+ Bone cement, tissue adhesives
e.Insect repellents
f. Body-building products containing protein/whey/ soya bean
g. Food - as defined under the Food Act 1983 and Food Regulations 1985, includes every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances. This includes food for special dietary use for persons with a specific disease, disorder or medical condition, and food which contain quantities of added nutrients allowable under the Food Act and Regulations.
* For information on Food - Drug Intephase products, please refer to subtitle 'Regulatory Information' > 'Other guidelines' > 'Classification decision tree' for further details.
h. Detergents/ disinfectants for domestic use
What is the procedure for the registration of pharmaceutical products?
Currently, only on-line submission is accepted for product's registration. This could be done by through NPCB's website www.bpfk.gov.my. An applicant must buy a membership for Quest before the applicant can proceed with registration. There are several packages available to choose to become a member of Quest. Any assistance/advice shall be forwarded to Digicert Customer Service Department: 03-89928888. Once the applicant has received the user and password from BPFK (via email), he/she will be able to enter the registration site and proceed with online submission. This online registration system is also applicable for NCE and bitoech products, traditional registration, re-registration of products and licensing.
The summary of the online registration procedure for products are as follows:-
1) Go to NPCB website (www.bpfk.gov.my)
2) Become Quest member (as First-time User)
* Requirements :
i. Company Registration Form
ii. Company Authorization Letter
iii. Photocopy of I/C 3) After making payment to Digicert, within 7 working days (East Malaysia might take more time), Digicert will send the Digital certifcate via POSLAJU. The login name and password will be emailed to the email address specified during the registration of Quest member.
4) With the login name and password, enter Quest, go under registration, and register the product on-line. All forms are available in the form tray.
5) Submit data requested
6) Correspondences with NPCB officer if additional data is needed
7) Products tabled to DCA meeting
The summary of the online registration procedure for products are as follows:-
1) Go to NPCB website (www.bpfk.gov.my)
2) Become Quest member (as First-time User)
* Requirements :
i. Company Registration Form
ii. Company Authorization Letter
iii. Photocopy of I/C 3) After making payment to Digicert, within 7 working days (East Malaysia might take more time), Digicert will send the Digital certifcate via POSLAJU. The login name and password will be emailed to the email address specified during the registration of Quest member.
4) With the login name and password, enter Quest, go under registration, and register the product on-line. All forms are available in the form tray.
5) Submit data requested
6) Correspondences with NPCB officer if additional data is needed
7) Products tabled to DCA meeting
What is the fee for drug registration?
Processing fee
Every application for registration shall be accompanied with a processing fee, as follows (effective January, 2007) :-
Applications without the correct fees will not be accepted. Foreign currencies are not acceptable. The processing fee is NOT REFUNDABLE.
Other charges
The DCA will charge any applicant such costs as it may incur for the purpose of carrying out laboratory investigations/ testing prior to the registration of any product.
Mode of Payment
The processing fee and any other charges shall be paid in the form of a bank draft/money order made payable to "Biro Pengawalan Farmaseutikal Kebangsaan".
NB. A separate bank draft is required for each application for registration.
Every application for registration shall be accompanied with a processing fee, as follows (effective January, 2007) :-
| No | Product Classification | Processing Fees (RM) | Analysis Fees (RM) | Total Fees |
| 1 | New Chemical Entity | 1,000.00 | Single active ingredient : 3,000.00 | 4,000.00 |
| Two or more active ingredients : 4,000.00 | 5,000.00 | |||
| 2 | Pharmaceutical | 1,000.00 | Single active ingredient : 1,200.00 | 2,200.00 |
| Two or more active ingredients: 2,000.00 | 3,000.00 | |||
| 3 | Traditional | 500.00 | 700.00 | 1,200.00 |
Other charges
The DCA will charge any applicant such costs as it may incur for the purpose of carrying out laboratory investigations/ testing prior to the registration of any product.
Mode of Payment
The processing fee and any other charges shall be paid in the form of a bank draft/money order made payable to "Biro Pengawalan Farmaseutikal Kebangsaan".
NB. A separate bank draft is required for each application for registration.
What is the next step to take after my product is registered?
After a product is registered, the applicant must apply for a manufacturer/ import/ wholesale license.
The processing fees are as below:
* Effective Date: 4 October 2007
The processing fees are as below:
| Licence | Registration fee | Time line * | Validity |
| 1. Import licence | RM 500 | Not more than 1 month | 1 year |
| 2. Manufacturer | RM 1000 | Not more than 1 month | 1 year |
| 3. Wholesaler | RM 500 | Not more than 1 month | 1 year |
* Effective Date: 4 October 2007
What is the timeline (time-frame) for registration?
The duration for each product to be registered is calculated from the date of final and complete submission.
Below are the timeline for product of each category:
* Update: January 2013
Below are the timeline for product of each category:
| Category of product | Timeline |
| Full Evaluation | |
To evaluate application for registration of :
|
|
| Abridged Evaluation | |
To evaluate application for registration of health supplements and traditional products containing:
|
|
What are the criteria for drug registration?
A product will be registered only if it satisfies ALL the requirements of the DCA, especially with respect to safety, efficacy and quality of the products.
Other criteria taken into consideration are:-
i. Whether that product is needed or not. Aspects like potential of abuse, number of registered products, different dosage forms, etc. are considered.
ii. Therapeutic effect.
Other criteria taken into consideration are:-
i. Whether that product is needed or not. Aspects like potential of abuse, number of registered products, different dosage forms, etc. are considered.
ii. Therapeutic effect.
Is all the information declared in the registration form confidential?
Yes, confidentiality of data is assured.
Can unregistered medicines for personal use be brought into Malaysia?
Under the Control of Drugs and Cosmetics Regulations 1984, the requirements for drug registration does not apply to a person who arrives in Malaysia and imports, as part of his personal luggage, any product for his use or his family's use, in a quantity that does not exceed one month's use by one person.