Chapter 1 Malaysia NPRA Regulatory information Brief

1. Eaa and Introduction

The National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health is responsible for the registration, review, quality management, supervision and regulatory administration of Health Supplements.

2. Supervision and regulation

Drug Registration Guidance Document, DRGD

Control of Drugs and Cosmetics Regulation 1984, CDCR

3. Definition and classification of health products

Definition of health food in Malaysia: products used to supplement diet and maintain human health, usually in capsule, tablet, powder, liquid form, do not contain sterile preparations.

Health products in Malaysia are classified into General or Nutritional Claims (general or nutritional Claims), Functional Claims (medium) (medium risk) : Functional Claims), Disease Risk Reduction Claims (high) (high risk reduction claims) three categories.

4. Entry requirement

• Power of attorney

• Pharmaceutical Certificate (CPP) issued by the competent authority of the country of origin

• Consider issuing countries: Australia TGA, China Administration of Traditional Chinese Medicine, European Commission, Health Canada, US FDA

• if If CPP is not available, a Free Sale Certificate (CFS), Good Manufacturing Practice (GMP) certificate must be issued by the competent authority in the country of origin/country of the product owner

• Importer information, product description

• Finished product COA

• Stability data, packaging and labeling inspection reports, process control documents, COA of active ingredients, etc
  

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5. Registration language 

English

6. Security Label (Hologram）Holographic anti-counterfeiting logo

According to Control of Drugs and Cosmetics Regulations 1984, mandatory implementation of anti-counterfeiting labels in registered health care products.

The holographic security marks are available from Techno Secure Print Sdn Bhd Company starting from 1 September 2019 at RM0.064 per tag.

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Classification flow chart

3.  Registration period and official fees

1）Registration cycle

2）Government fee

Chapter 3 FAQ 

Q：Can I change the label/formulation of my product after registration?

A：Agreed. An application to modify the details of a registered product can be submitted online through Quest. Some changes/amendments require prior approval from the NPRA before they can be implemented. Approvals and decisions will be notified online. If a change in the active substance is involved, the formulation of the product cannot be changed. In this case, a new application must be made.

Q：Do companies outside Malaysia need to appoint a local agent if they want to register their healthcare products in Malaysia?

A：Yes. The foreign company must appoint a local agent, i.e. a business company registered in Malaysia, as the holder of the certificate of incorporation. The Malaysian agent will be responsible for communicating with the regulatory authorities related to product registration. Products registered with the Drug Administration must indicate the name and address of the actual manufacturer and importer on the label.