Who is the Drug Control Authority in Malaysia?

The Drug Control Authority (DCA) is the executive body established under the Control of Drugs and Cosmetics Regulations 1984. The main task of this Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia.

What is the equivalent of FDA in Malaysia?

The Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH), oversees drug registration.

Is DCA under NPRA?

The DCA is a eleven-member executive committee chaired by the Director- General of Health and comprises of the Senior Director of Pharmaceutical Services, the Director of NPRA plus eight other appointed members including a consultant physician in public service, a pharmacist in public service, three persons from any …

What does the NPRA do?

Regulation Basics

NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. This is achieved through evaluation of scientific data and laboratory tests on all products before they are marketed.

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How pharmaceuticals are being regulated in Malaysia?

The DCA oversees the registration of pharmaceutical products and cosmetics, licensing of premises (for importers, manufacturers and wholesalers) and monitoring the quality of registered products and Adverse Drug Reactions (ADR).

What is not Malaysia?

Dzaharudin Mansor is the National Technology Officer (“NTO”) for Microsoft Malaysia. As the NTO, Dzahar drives the engagement with key national technology stakeholders, which include academics, policymakers & advisors, and interest groups with the intention to builds trust while contributing to national development.

Does Malaysia have FDA?

IAS and its FDA registration services in Malaysia

We offer FDA registration services in Malaysia and also various countries across the globe.

What is DCA in pharma?

DCA cancer treatment. Dichloroacetate, or DCA, is a synthetic chemical used for cosmetic and clinical purposes. It’s commercially available as a cauterizing agent, meaning it burns the skin. This drug became popular in 2007 after a Canadian study suggested DCA might be able to reverse cancer growth.

What is the function of DCA?

Dichloroacetate (DCA) is a metabolic modulator that inhibits mitochondrial pyruvate dehydrogenase kinase and increases mitochondrial oxidative phosphorylation. DCA also depolarizes the mitochondria, causing release of H2O2 and cytochrome c.

When was the Drug Control Authority established?

The Department of Narcotics Control was established on 2 January 1990 under the Ministry of Home Affairs and is related to National Narcotics Control Board.

What does NPRA mean?

NPRA

Acronym Definition
NPRA National Petrochemical and Refiners Association
NPRA National Petroleum Reserve in Alaska
NPRA National Petroleum Refiners Association
NPRA National Professional Rodeo Association
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What is moh certificate?

All medicinal products in Malaysia, including imported medicines, must be registered with the Ministry of Health Malaysia (MOH) before they can be sold or marketed to consumers. Registered products are guaranteed in terms of Safety, Quality and Efficacy.

What are the objectives to be achieved through the establishment of the Drug Control Authority *?

This objective is being achieved through the following: Registration of pharmaceutical products and cosmetics. Licensing of premises for importer, manufacturer and wholesaler. Monitoring the quality of registered products in the market.

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 considered Pharmaceutical?

Pharmaceutical Products means any product, compound, medicine or therapeutic which is subject to regulation as a drug, medicine or controlled substance by a foreign equivalent of the United States Food and Drug Administration.

What is reimbursement Pharma?

Reimbursement is therefore the negotiation of a price between manufacturer and payer that allows the manufacturer access to that market. … Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients.