As part of the contract manufacturing of medicines, we offer our clients assistance in the registration of medicinal products.
As a company specialising in comprehensive contract development and production of medicinal products, we select the appropriate registration strategy for our clients and carry out subsequent stages of product development. In accordance with current legal requirements and ICH guidelines, we aim to register the drug in Poland and the European Union. We prepare complete registration documentation in CTD/eCTD format and conduct the registration process of the medicinal product in the national or European procedure.
In addition, at the client’s request, we conduct a dossier audit (QC), which consists in checking the registration dossier to assess its completeness and the possibility of its continued use.
The procedure for the registration of a medicinal product is a complex process subject to many national and European laws, which impose on a manufacturer of medicinal products the need to conduct extensive studies to demonstrate the appropriate quality, efficacy and safety of the medicinal product before it is granted marketing authorisation. The data obtained during the tests are collected in the required registration documentation, which is subject to rigorous evaluation by registration agencies in each country.
The process of introducing a medicine to the market is a time-consuming and complicated activity, involving many elements, including research and development works, technological trials, stability and microbiological studies of the drug, as well as preparation of documentation. The last necessary element before placing a product on the market and starting its commercial production is registration.
In Poland, for example, the authority responsible for the granting marketing authorization for medicines is the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Prior to registration, a number of legal standards must be met under the Pharmaceutical Law Act and the EU Directive 2001/83/EC implemented therein. The process of releasing a drug on the market itself should not exceed 210 days. During the registration process, ethical aspects are also taken into account, which means that the entity registering a given medicinal product should be driven by patient welfare rather than financial benefits.
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