title: [Approval of drugs by national and European agencies--sequelae for the pharmaceutical industry].
abstract: The research-based pharmaceutical industry supports the European harmonization process for the granting of pharmaceutical registrations. In order to improve consumer protection and the therapeutic options available to physicians in comparison to nationally registered products, the harmonization must be carried out on schedule and transparently a high scientific standard. It must not lead to the adoption of all national restrictions regarding data sheets and patient leaflets. Pharmaceutical products with the same ingredients can be registered either through the national or through the European procedure. This situation can only be remedied by the harmonization of core SPCs. This process must be agreed in consultation between pharmaceutical companies and regulatory authorities. With regard to measures to avert drug risks, professional associations and the pharmaceutical companies affected should be heard by the national authorities and their arguments given due consideration. In addition, national authorities and the CPMP must coordinate their decisions before they are published. In particular, the basis of these decisions should be made clear and therapeutic alternatives should be known.
authors.affiliation: MSD Sharp & Dohme GmbH, Haar.
authors.forename: O
authors.initials: O
authors.lastname: Zierenberg
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D003431:Cross-Cultural Comparison; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D005858:Germany; D006801:Humans; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence
vernacular_title: Zulassung von Arzneimitteln durch nationale und europäische Behörden--Konsequenzen für die pharmazeutische Industrie.