Before being placed on a market each medicinal product is evaluated during the process of registration. Four registration procedures are applicable in the European Union, namely: centralized procedure (CP) under responsibility of the EMEA (European Medicines Agency) located in London, decentralized procedure (DCP), mutual recognition procedure (MRP) and national procedure under responsibility of national regulatory authorities, in Poland of the Office for Registration of Medicinal Products, Medical Devices and Biocides. The Quality of medicinal product is assessed on the basis of chemical, pharmaceutical and biological documentation provided by an applicant and for an active substance by its manufacturer (closed part of DMF) in most cases directly to the regulatory authority. The above mentioned documentation forms Module 3 of Common Technical Document (CTD) and its summary is included in Module 2 as Quality Overall Summary. CTD consists of five modules containing also documentation on safety (Module 4) and efficacy (Module 5) of medicinal products. The Assessment of chemical, pharmaceutical and biological documentation is performed with respect to its conformity to the requirements of EU Directives, Regulations (in Poland Pharmaceutical Law and Regulations of the Minister of Health), European Pharmacopoeia (or, failing this to pharmacopoeia of a Member State) and guidelines of CPMP, ICH and WHO. These legal acts and guidelines define in details the way the tests should be performed as well as the interpretation of the results. According to Annex to Module 3 (part A of the Annex) 10 general and 46 detailed guidelines are in force. Detailed requirements for biotechnological substance as well as for medicinal products containing these substances are much wider in comparison to synthetic substances. Manufacturing of active substances on the basis of biotechnological methods using cell banks of microorganisms, plants or animals origin is so specific that the additional guidelines (14 general and 27 detailed) included into part B of the above mentioned Annex were predicted. The Assessment of quality of medicinal products on the basis of chemical, pharmaceutical and biological documentation provided for procedures CP, MRP and DCP is completed by issuing Quality Assessment Report (English language, strictly formalized structure of the document). For national procedure the assessment of quality documentation may be written in national language (in Poland only in Polish version). The information on structure and content of registration dossier is available on the following websites: www.emea.eu.int and pharmacos.eudra.org

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1. Experience of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in assessment of quality of medicinal products
2. The Pharmacopoeia in preparation and assessment of pharmaceutical, chemical and biological documentation of medicinal products
3. Registration dossier of chemical active substance