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The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [ 3 ]
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children. For this purpose, new data used for PUMA approved drugs are protected for 10 years, and the applications are partially exempt from fees. [1] In September 2011, the first drug was approved under this process.
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products Directive 75/318/EEC , clarifies requirements of 65/65/EEC1 and requires member states to enforce them Directive 75/319/EEC , requires marketing authorization requests to be drawn up only by qualified experts
It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. [1]
The EDQM also hosts the publicly available Melclass database, [25] which presents the classification status of medicines in Ph. Eur. member states. Setting quality and safety standards in pharmaceutical practices and pharmaceutical care: public authorities and the pharmaceutical industry devote much of their resources to ensuring the quality ...