After a successful test phase, ANSM has decided to maintain its two accelerated circuits for medicinal product clinical trial authorisations (Fast Track). These circuits were established on 15 October 2018 as an initial test run and on a voluntary basis to reduce clinical trial authorisation...
Read moreAs mandated in Article 4 of Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (ATMPs), the European Commission has published guidelines on good clinical practice (GCP) specific to ATMPs. The 15-page document should be read in conjunction with ICH E6 Guidelines on GCP , which are...
Read moreNitrosamine impurities were previously detected in batches of medicines containing the Angiotensin-II-receptor antagonist valstartan, leading to worldwide recalls of batches . Since the initial findings, nitrosamine impurities have been detected in some batches of other medicines including the...
Read moreFrom the 21st to the 24th of September, EUDRAC will be exhibiting at the RAPS Convergence 2019 in Philadelphia, Birthplace of the USA. Our team’s experts cover a vast spectrum of expertise, ranging from Small Molecules to Advanced Therapies, and from successful Dossier submissions to the...
Read moreClinical trials are an important step during drug development, leading towards marketing authorisation and thus, market access. According to §40 German Drug Law / §7 GCP ordinance, clinical trials have to be approved by the responsible competent authority (CA). Recently, both German CAs (the...
Read moreThe SmPC can be viewed as a contract between the marketing authorisation (MA) holder of a medicinal product, who drafts the document, and the regulatory agency, who reviews the document. It contains all the relevant product-specific efficacy and safety information and thus provides the very basis...
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