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Lifesciences Compliance Services In Malaysia
Streamlined Regulatory Compliance from product registration, market access and lifecycle maintenance in Malaysia.
Artixio is the most preferred global market regulatory services provider which serves as the fuel you need to accelerate your regulatory process in Malaysia. We have the most professional expertise to assist you in your hassle-free regulatory journey. Our dedicated team in Malaysai is there right from the registration to the market access and post-marketing surveillance. We, as the key global partner, stay updated with all the recent updates in NPRA regulations and provide complete support in designing customized regulatory strategies and achieve timely submissions.
The Regulatory Process In Malaysia
The regulatory procedure in Malaysia is governed by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health (MoH) Malaysia. It is responsible for all the products registrations and approvals. Some other regulatory authorities in Malaysia work such as Medical Device Authority (MDA) for medical devices Registration Guideline Of Veterinary Products (REGOVP) for animal health products, etc.
Working of National Pharmaceutical Regulatory Agency (NPRA):
MoH governs NPRA, which is responsible for the registration and approval of pharmaceuticals, biologics, cosmetics, and animal care products in Malaysia. NPRA is the main regulatory body in Malaysia. All the new products are required to register with NPRA for approval and the confirmation of their safety and efficacy the nee new product gets approved by NPRA. The primary requirements of NPRA on the registration form are the product name, registration number, registration name, manufacturer’s name, importer and active content.
Our Expertise In Regulatory Services In Malaysia:
We have years’ long experience in the field of regulatory services, working in 120+ countries to help establish a strong regulatory pathway and expediate the approval workflow for rapid market entry in Malaysia. We are aimed to provide you seamless services with the following products:
Pharmaceuticals
The registration and approval of pharmaceuticals in Malaysia is regulated by NPRA under the MoH.
Biologics
For the biologic products rules and regulations by NPRA are enforced with the registration and marketing norms by Control of Drugs and Cosmetic Regulations (CDCR).
Medical Devices
The regulation of Medical Devices is regulated by Medical Device Authority (MDA) under MoH.
Cosmetics
NPRA overlooks the regulatory process of cosmetics in Malaysia.
Food Supplements
The food supplements approval and registration process is also governed by the NPRA in Malaysia.
Animal Health Products
For Animal Health Products the NPRA regulates the approval process following the guidelines from REGOVP.
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Industries We Serve in the Malaysia
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
What are the regularties bodies working in Malaysia for pharmaceuticals, medical devices, animal care, veterinary products, beauty and wellness products?
In Malaysia the regulatory bodies responsible for pharmaceuticals and beauty products is the National Pharmaceutical Regulatory Agency (NPRA), Medical Device Authority (MDA) for medical devices, Department of Veterinary Services (DVS) for animal wellness and veterinary products. All these authorities work under Ministry of Health (MoH Malaysia).
How can the regulatory bodies be approached in Malaysia?
The regulatory bodies such as NPRA, MDA, DVS etc can be approached through official email-ID whcih is npra@npra.gov.my for NPRA, mda@mda.gov.my for MDA and info@dvs.gov.my for DVS. These official authorities can also be reached out through their contact number on the official website or through the Malaysian local representative.
Which is the reference regulatory authority in Malaysia?
NPRA for pharmaceuticals and wellness products, MDA for medical devices and DVS for animal wellness and veterinary products serves as the reference regulatory authorities in Malaysia.
How can a foreign manufcaturer register its product in Malaysia?
A foreign maufacturer can register its product in Malaysia by appointing a local representative, who is responsible for fulfiling all the regulatory requirements on behalf of the foreign manufacturer and meeting the compliance requirements.
What are basic documents required for registration of pharmaceuticals, medical devices, animal care, veterinary products, beauty and wellness products?
The basic documents for pharmaceuticals are the manufacturing license, GMP certification, safety, efficacy, and stability data for medical devices thedocuments required are product information, GMP certificate, Certificate of conformance, risk management file, etc. And for veterinary products, the documents required are the product dossier, product safety and efficacy data and for beauty and wellness the documents required are safety assessment data, GMP compliance certificate, labelling compliance certificate.
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