Registration Consultancy

Regulatory Services in Malaysia

Malaysia’s pharmaceutical market is one of the fastest growing in Asia Pacific. The country’s pharmaceutical industry is strong, providing mostly basic generics. The market is, however, dependent on imports for the supply of expensive patented and newer generation medicines.

The pharmaceutical market is rapidly expanding at a compound annual growth rate of over 9.5%.

In 2016, the Malaysia Pharmaceutical market stood at $2 billion with imports accounting for over 65%. The imports are helped by reasonable, predictable and pragmatic approach of the regulatory authority. With Malaysia being a part of ASEAN Mutual Recognition Arrangement, repeated audits have only reduced thus paving way for speedy clearances.

Regulatory Authority

National Pharmaceutical Regulatory Agency

and Medical Device Authority

Market Size

Expected to touch USD 3.6b by 2020, majorly dominated by imported products.

Regulates

Drugs, OTC, Medical Devices, Cosmetics, Food

Local Industry

Approximately 250 local drug manufacturers with majorly manufacturing older generics.

Why partner with Genedrift

"Time isn't the main thing, It is the only thing"

- From start to end, we offer it all, in addition to ensuring the safety and security of your registrations.
- With no commercial interest in products, we hand the registrations to you as soon as received and ensure un-hindered business from your registrations
- Communicate with us over email or Whatsapp or Viber, whatever is comfortable with you. Our team is spread across various geographies, offering excellent customer support.

Resources

Want to read and understand more about the regulatory procedures, follow the above link.

Speed & Accuracy

We ensure that your application are correctly filled, and they move through the right departments and procedures in the NPRA.

Safety of Data

Preventing any data leaks and unwanted access to your data, we carefully control access of each employee to customer data.

Pre-Review

All applications and dossiers are reviewed internally before being forwarded to NPRA saving applicant time and money, both.

Start to End

Providing a customized solution, from the very start to the last stage, all activities can be outsourced, and you can focus on other activities at hand.

Local Entity

Genedrift is a local company as per the laws of Malaysia and employs full time staff to cater to all regulatory needs.

Original Handling

Handles your registration certificates and keeps custody, preventing any business disputes holding your sales.