How can I register my pharmaceutical product in Malaysia?

All pharmaceutical products must be registered with the Drug Control Authority before it can be marketed in Malaysia. A foreign company wishing to bring pharmaceutical products into Malaysia would first have to appoint a local agent (a company registered in Malaysia) to be the holder of the registration certificate.

What is pharmaceutical registration?

“Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved / registered / marketed in a country.

How do I register a new drug?

Applications for Registration/ Import License of New Drugs shall be submitted to the Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), FDA Bhawan, ITO, Kotla Road, Delhi-110002. Phone: 91-11-23236965 /23236975. Fax: 91-11-23236973, as per Drugs & Cosmetics Rules in India. Q12.

How do you know if a product is pharmaceutical or registered drugs?

To check the list of products registered with the DCA, visit the official website of the National Pharmaceutical Regulatory Agency, www.npra.gov.my. Click on the ‘Registered Product Search’ (Quest 3) and enter the details of the product to start the search.

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What is a registration dossier?

Registration Dossier means a written regulatory submission or document describing Product Specifications and manufacturing methods as submitted by Company and approved by the applicable regulatory agency and Distributor.

What documents are required for new drug approval?

The date regarding the trial protocol, investigator’s brochures, and informed consent documents should also be attached. A copy of the application must be submitted to the ethical committee and the clinical trials are conducted only after approval of DCGI and ethical committee.

How much would it cost for a company to develop a new drug and bring it to market?

Developing a new prescription medicine that gains marketing approval is estimated to cost drugmakers $2.6 billion according to a recent study by Tufts Center for the Study of Drug Development and published in the Journal of Health Economics.

How do I submit an FDA approval?

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

How do you check if a product is registered with KKM?

Users can check the registration status of a product through the https://www.npra.gov.my / OR by contacting the National Pharmaceutical Regulatory Agency at 03-78835400. If the product is a registered product, the registration status will be displayed.

What are pharmaceutical products?

Pharmaceutical Products means any substances resulting from preparing, preserving or compounding of medicinal drugs, vitamins or other materials used to enhance personal health.

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What is Mal registration?

Every pack of medication and cosmetics, if it is registered under the Drug Control Authority and does not contain any restricted substances, will be given a MAL number. … The MAL registration number is a useful tool to inform consumer about cosmetic products.

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