The PRAC will endorse the advice relating to PASS, and a Final Advice Letter will be issued. Procedures that contain only centrally authorised products (CAP(s)), Procedures that contain a mix of centrally authorised products (CAP(s)) and nationally authorised products (NAP(s)), Procedures that only contain nationally authorised products (NAP(s)), The preparation of the translation process. The MAH(s) should submit a clean and a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation. Non-interventional imposed PASS will be assessed by the Pharmacovigilance Risk Assessment Committee (PRAC), except for studies to be conducted in only one Member State requesting the study according to Article 22a of Directive 2001/83/EC. However, Applicants should duly consider the best timing for their request for scientific advice, i.e. In summary, scientific advice will follow the same procedure as other scientific advice with the exception of involvement of PRAC, the appointment of PRAC peer-reviewer, and endorsement of the letter by PRAC. What is the format of the briefing document? The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. EMA provides useful guidance on the submission of post-authorisation data on the questions and answers (“Q&A”) published in EMA’s website. the medicine is prescribed in the usual way in accordance with the terms of the, deciding how to treat the patient is based on current practice and not a. the prescription of the medicine is clearly separated from the decision to include the patient in the study; patients do not undergo additional diagnostic or monitoring procedures; data analysis uses epidemiological methods, for CAPs and NAPs: to be submitted to EMA in eCTD format only via the eSubmission Gateway or eSubmission Web Client (as per Dossier requirements for, a letter notifying the MAH that the study is a. a letter of objection specifying the grounds of objection and the timelines for resubmission and reassessment of the protocol; a letter of endorsement of the draft protocol. EMA has published guidance on the format and content of study protocols and final study reports for non-interventional studies, together with the PRAC assessment report templates. The Agency will monitor the quality of the translations, the review by the Member States and MAHs' compliance with the Member States' comments as part of the Performance Indicators. information. Dossier requirements for referral, ASMF and NAP submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device. format, layout and margins). Will the EMA support for these protocols be different from any other scientific advice? Please give as much detail as possible when completing your request and be sure to include your correct and complete contact details. The name of the appointed PRAC Rapporteur will be communicated to the marketing authorisation holder by EMA at the start of procedure. scientific advice procedure 2. You will be able to contact this RMS throughout the procedure. PASS 107 submissions are available to the NCAs via the Common Repository. EMA publishes the outcomes of final study results of non-interventional imposed post-authorisation safety studies (PASS) for NAPs on the EMA website. What type of question is expected to be raised for the concerned study protocols? EMA will send the package to the CMDh and prepare the translations for publication. variation, suspension or revocation of the marketing authorisation, the PRAC recommendation will be transmitted to the CHMP if it includes at least one CAP or to the CMDh if it includes only NAPs. This is known as the post-authorisation stage of the product lifecycle. 1 Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency, 2Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures EMA/MB/530034/2014. Information regarding the discussion meeting is provided in the FAQ 21 “ The EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation Individual Case Safety Reports (ICSRs) as required by Regulation (EC) No 726/2004, Directive 2001/83/EC as amended. In general, any question pertaining to the draft protocol can be posed in the draft briefing document. Imposed non-interventional PASS final study reports should be submitted in module 5.3.6 of the CTD. In order to facilitate and accelerate the check of the implementation of the comments, the MAH should indicate in “ For non-imposed PASS (category III), is it mandatory for companies to submit the study protocols to PRAC? Amendments are considered substantial when the changes proposed are likely to have an impact on the safety, physical or mental well-being of the study participants or that may affect the study results and their interpretation, such as changes to the primary or secondary objectives of the study, the study population, the sample size, the study design, the data sources, the method of data collection, the definitions of the main exposure, outcome and confounding variables or the statistical analytical plan as described in the study protocol. products not listed in the Annex to the CHMP opinion or CMDh position) might be affected by the outcome and should implement accordingly when the adopted changes are applicable to their MA. The European Medicines Agency (EMA) has released guidance on methods to be used in the design and conduct of post authorisation efficacy studies. These include studies that are a specific obligation for a marketing authorisation granted under exceptional circumstances and other studies that the PRAC requests the company carry out. A dedicated meeting with the PRAC Rapporteurs may be organised to support interactions between the MAHs and to provide suggestions for the joint study proposal. Guide on The EMA highlights in the guidance document that the … Any additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. can be completed and submitted. Interim results and/or feasibility studies of non-interventional imposed PASS do not fall under the provisions in Articles 107n-q of Directive 2001/83/EC. For questions related to fees, please use the dedicated The results of non-interventional imposed PASS should be evaluated by the MAH(s), who should consider whether the results have an impact on the marketing authorisation. Article 107p. The revised product information of the product(s) concerned should be presented in English language in module 1.3. MAHs should translate for their products all relevant Annexes. For CAPs, the PRAC Rapporteur will be the one already appointed for the product. This is known as the post-authorisation stage of the product lifecycle. In general, any question pertaining to the draft protocol can be posed in the draft briefing document. Applicants/MAHs wishing to request scientific advice on specific aspects of PASS protocols /or joint protocols by a consortium of MAHs for PASS imposed as conditions to the marketing authorisation (i.e category I and II PASS), can also submit a SA request. The final advice letter is endorsed by the PRAC and adopted by the CHMP through a written procedure before sending to the MAH/Applicant. whether at the moment of the submission there are sufficient certainties about the status and the objectives of the study. How will the PRAC Rapporteur for a product be involved in the scientific advice? For CAPs, the PRAC Rapporteur will be the one already appointed for the product. Changes in the milestones affecting the timelines for the submission of the final study reports should be considered as substantial amendments to the protocol and should consequently be submitted for assessment to the PRAC as an Article 107o procedure. Amendments to the summary of product characteristics (SmPC), labelling and package leaflet (PL) as a result of the PASS final study report assessment are directly implemented through the EC decision for centrally authorised products and through the appropriate variation at national level for nationally authorised products (including those authorised through the mutual recognition and decentralised procedures). Points of interest April 2014 Delegated Regulation, 1st PAES imposed CHMP June 2014 ) ... European Medicines Agency Keywords: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure . The guideline is primarily aimed at marketing authorization applicants and holders planning to conduct registry studies in the pre- or post-marketing authorization phase. For clinical trials, MAHs should follow the instructions in volume 10 of the rules governing medicinal products in the European Union (EU). For CMDh position by consensus (no EC decision adopted): As per the date indicated in the translation timetable i.e. The assessment of a non-interventional imposed PASS final study report is performed by the PRAC. For joint studies, the contact point of the marketing authorisation holders or consortium may be contacted for financial purposes. Translation of the adopted Annexes in EN and in all other EU languages (and in Icelandic and Norwegian) are to be compiled and provided electronically (in one Eudralink package if applicable) to the EMA procedure assistant. Protocols and protocol amendments (Articles 107n-o). See link here. EMA regularly updates the Q&A to reflect new developments, additional guidance and the implementation of new European legislation. Post-authorisation The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. Marketing and cessation requirements involve informing the agency when a product is placed on or taken off of the market. MAH(s) should enter in the European Union electronic Register of Post-Authorisation Studies (EU PAS Register) protocols and public abstracts of results of non-interventional imposed PASS conducted in accordance with Articles 107n-q of Directive 2001/83/EC within one month after the relevant PRAC recommendation. Will fees be levied for scientific advice provided for PASS protocols? This person will be the primary contact point on all interactions with EMA and will receive the documentation relevant for the procedure. For NAPs, a PRAC Rapporteur will be appointed upon receipt of a PASS protocol. The revised protocol can then follow subsequent 60-day assessment procedures as per the timelines above until it is fully endorsed by the PRAC. Figure 1: Overview of scientific advice procedure on PASS. In stark contrast, the EMA guidance stipulates the only alternative is a co-primary endpoint that has both resolution of NASH and improvement in fibrosis. Please see the published Ready availability of relevant documents and references facilitates assessment. The MAH(s) will implement the required changes. Importantly, only study reports that are considered final by the MAH(s) should be submitted to the Agency. The submission should include a cover letter and in order to facilitate the registration of the submission, the eSubmission delivery file should be duly completed as required for the procedure. Member States (MS) Contact Points for Translations The assessment under a 107q procedure is as follows, regardless whether it refers to one or more centrally authorised medicinal products, a mix of centrally authorised medicinal products and nationally authorised products, or nationally authorised products only. As per existing scientific advice procedures, the assessment is led by SAWP delegates acting as SAWP coordinators. Voluntary PASSs are sponsored or conducted by MAHs on their own initiative. In case of a joint PASS (i.e. for many FAQs. EMA scientific advice guidance They aim to: PASSs can either be clinical trials or non-interventional studies. The Agency will inform the MAH of the outcome of the validation and procedural . Any response to a request for supplementary information must be sent to EMA, the PRAC Rapporteur and all PRAC members as per above requirements. Independently of the MAH(s) evaluation of the need for a variation, and following the assessment of the final study report, the PRAC may issue a recommendation to the Committee for Medicinal Products for Human Use (CHMP) for any regulatory action that is deemed to be appropriate. Scientific advice on safety studies is a voluntary procedure for Marketing Authorisation Holders (MAH) or Applicants, and complementary to existing ones. How will scientific advice procedures for safety studies be run? The Agency will inform the MAH of the insufficient quality of the translations and the transmission to the EC will be delayed until receipt of the amended translation (which would be expected within 1 week). The following requirements are related to the non-interventional imposed PASS protocols and final study report which are supervised by the PRAC. Procedures for PASS protocols will not be handled any differently than for existing scientific advice procedures except the extension to and inclusion of PRAC interactions and relevant Agency staff, such as the Risk Management Specialist. If the MAH(s) concludes that this is indeed the case, the MAH(s) should submit the results directly as an application for variation to the relevant competent authority. For this purpose, the definitions included in Article 37(2) of Commission Implementing Regulation (EC) No 520/2012 (“End of data collection means the date from which the analytical dataset is completely available”) and GVP Module VIII (“Analytical dataset: the minimum set of data required to perform the statistical analyses leading to the results for the primary objective(s) of the study” – Section VIII.A.1. They include non-imposed studies that are requested in risk management plans. European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. What is the nature of the discussion meeting? Is the necessary expertise available in SAWP to evaluate PASS protocols? Substantial amendments of an agreed protocol – Article 107o procedure. Day 25 (25 days after opinion / position). A pre-submission meeting with Agency staff will be arranged to consider the suitability and validity of the submission. For pre-submission queries that are not covered by this guidance please submit your query using the following web form. QRD Form 2 In case of incomplete or incorrect data in the web form, the request may not be processed. By engaging in scientific advice on PASS, Applicants or Marketing Authorisation Holders (MAH) can benefit from, Which post-authorisation safety studies could benefit from scientific advice? For further details on fees and fee incentives/reductions please consult the Explanatory Note on fees payable to the EMA and the section on fees on the Agency's website. 1 Systematic reviews and meta-analyses of safety data should be considered as non-interventional PASS. More information on how to provide documents to the EU PAS Register for PASS studies can be found here: EU PAS Register. In this case no stand-alone RMP variation is necessary further to the draft protocol can then follow 60-day. 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