Facilitating submission of post-approval data
EMA implements new submission form for post-authorisation measures
The European Medicines Agency (EMA) has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures(PAMs) for centrally authorised products.
PAMs require marketing authorisation holders (MAHs) to provide additional data on the safety, efficacy or quality of the medicine once it is authorised. They fall into several categories, depending on their legal basis and the type of data to be generated. PAMs can be agreed by the Committee for Medicinal Products for Human Use (CHMP), the Committee for Advanced Therapies (CAT) and the Pharmacovigilance Risk Assessment Committee’s (PRAC).
The new form helps to simplify the submission process for PAMs. Upon completing the form, the MAH is automatically informed of the category of PAM and the submission type and code for the eSubmission Gateway. The MAH also receives useful procedural information, including the timetable, the EMA committees involved and the EMA resources assigned.
The easy-to-use form is an integral part of the regulatory submission package and its use is mandatory from 1 September 2017. The form will be part of module 1.0 of the electronic common technical document (eCTD) submission.
Latest News from
Payment services: Consumers to benefit from cheaper, safer and more innovative electronic payments15/01/2018 16:25:00
The revised Payment Services Directive (PSD2), which will apply as of 13 January 2018, aims to modernise Europe's payment services to the benefit of both consumers and businesses, so as to keep pace with this rapidly evolving market.
PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market15/01/2018 14:20:00
Review finds measures to protect patients have not been sufficiently effective.
Public consultation: guidance on nanomaterials15/01/2018 13:10:00
EFSA has opened a public consultation on its draft guidance for the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. The guidance covers the relevant areas within EFSA’s remit, such as novel foods, food contact materials, food and feed additives, and pesticides.
ESMA raises concerns on fees charged by CRAs and Trade Repositories12/01/2018 15:10:00
The European Securities and Markets Authority (ESMA) has published a Thematic Report on fees charged by Credit Rating Agencies (CRAs) and Trade Repositories (TRs), following the conclusion of ESMA’s supervisory review of the current fee structures in the credit rating and trade repository industries.