Sometimes you've just got to get it off your chest. This article is a humorous take on the regulatory submissions process and the drama it can entail for the regulatory team. Elisabeth Kübler-Ross identified the five stages of grief as denial, anger, bargaining, depression and acceptance. Regulatory submissions are really no different. First comes a proposed submission date from management. It is clearly impossible. Surely that is apparent to all involved. It's ...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is "strongly" encouraging all applicants to participate in its pilot participation in the Central European Submissions Platform (CESP), an online-based secure submissions system. Currently, applicants are permitted to submit applications to MHRA using data contained on CDs or DVDs, depending on the size of the submission. However, this submission style necessitates manual handing of media, storage spac...

Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers to the agency. Health Canada said in April 2012 it is moving entirely to an eCTD format for all applications of pharmaceutical products after the non-eCTD applications were seen as a burden on the agency. "Health Canada is considering ending the Non-eCTD Hybrid Pilot at the e...

Several innovations are currently being discussed or implemented by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). One key innovation area is the assessment of a medicinal products benefit-risk. A major focus is assessment of whether drug, device and biologic products have an appropriate benefit-risk balance for marketing approval and continued marketing. Recent International Conference on Harmonisation (ICH) guidelines, European legi...

The Irish Medicines Board (IMB) is announcing its adherence to a 2005 agreement between the Heads of Medicines Agencies to transition to a fully electronic system for submitting applications, including the electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS). IMB said in a statement the transition confers several advantages, including reduced costs, consistency of applications and information viewed across agencies, improved lifecycle ma...

The European Medicines Agency (EMA) has released a new reflection paper on the classification of advanced-therapy medical products (ATMPs)-therapies made from genes and cells-which aims to clarify the legal basis for the classification of advanced therapies and provide information to applicants on how to submit applications for approval to EMA. In particular, the paper "provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tiss...

Health Canada is announcing its intent to shut down a pilot project currently used by sponsors who still wish to submit common technical documents (CTDs) in their physical format instead of the now-common electronic CTD (eCTD) format. Health Canada's pilot project, which involves the sponsor filling out CTDs in electronic format and submitting them in their physical form to Health Canada, was intended to be a "transitory aid for sponsors not yet ready to submit in eCTD f...