After this deadline, the Agency will contact MAH(s) to make sure the information is available in the register and, unless alternative timelines are agreed, will enter the information on its own initiative in order to fulfil its legal obligations under Article 26(1)(h) of Regulation (EC) No 726/2004. 4.1. Last week, European Medicines Agency (EMA) updated the guidance document “ European Medicines Agency post-authorisation procedural advice for users of the centralised procedure ”. The timelines for assessment are 60 days, the following timetable shall apply: Start of the procedure according to the published timetable, PRAC Rapporteur's preliminary assessment report, PRAC Rapporteur's updated assessment report (if necessary). How do I prepare for a Discussion meeting? . . The MAH(s) will implement the required changes. Further guidance is provided in GVP Module VIII and in the EMA Guidance for the format and content of the protocols and the final study reports of non-interventional post-authorisation safety studies. 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 EMA also updates the Q&As to include guidance on further post-authorisation procedures. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing their results. This guidance document addresses a number of issues that marketing authorisation holders (MAHs) may have on post-approval procedures and provides an overview of the Agency’s position on … The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. A further PRAC peer-reviewer is appointed to provide additional product specific PRAC input. The EMA highlights in the guidance document that the … A list of issues for discussion at the Discussion meeting is sent to the MAH/Applicant (See figure 1 below SAWP 2). QRD Form 2 The European Medicines Agency (EMA) has released guidance on methods to be used in the design and conduct of post authorisation efficacy studies. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure; These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants. EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. The following requirements are related to the non-interventional imposed PASS protocols and final study report which are supervised by the PRAC. first instalment (40%) for the assessment of the draft protocol (Article 107n of Directive 2001/83/EC); second instalment (60%) for the assessment of the final study report by the, a lifecycle approach to medicines advice with integrated advice on all aspects of medicines development from involved Committees, advice at an early or late stage of the protocol development, a pre-submission interaction with Agency secretariat to consider suitability and validity of the dossier, a face to face meeting with involved regulators during the procedure, options to include other stakeholders such as HTAs or FDA further supporting optimised evidence generation. However, some MAH/Applicant can choose not to request one. Where can I find further information about scientific advice? Annex I (scientific conclusions and grounds for, Annex III or IV (timetable for implementation, The structure of the English Annexes has to be strictly followed and should be exactly translated as per the adopted English version (i.e. can be completed and submitted. The outcome for nationally authorised medicinal products included in 'mixed' procedures where centrally authorised products were also involved can be found on the Community register maintained by the EC. In this context, two different types of scientific advice fees are applied depending on whether the request is an 'initial request' or a 'follow-up'. This is known as the post-authorisation stage of the product lifecycle. Please refer to the individual . Please give as much detail as possible when completing your request and be sure to include your correct and complete contact details. The European Medicines Agency (EMEA) has released an updated post-authorization guidance. According to Article 26(1)(h) of Regulation (EC) No 726/2004, protocols and public abstracts of results of non-interventional PASS imposed in accordance with Article 10 or 10a of Regulation (EC) No 726/2004 or with Articles 21a or 22a of Directive 2001/83/EC shall be made public by the Agency. Subsequently, where the procedure includes at least one CAP, the EC will adopt a decision to the MAHs for the centrally authorised products and, as applicable, to the competent authorities of the Member States for nationally authorised products. [or Request for Supplementary Information], CHMP opinion / CMDh position (in case PRAC recommends a variation, suspension or revocation of the MA). Any response to a request for supplementary information must be sent to EMA, the PRAC Rapporteur and all PRAC members as per above requirements. The rules governing non-interventional imposed PASS are set in Articles 107n-q of Directive 2001/83/EC. ”. The information in this section sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls. The purpose of the information in PASSs is to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making. They include non-imposed studies that are requested in risk management plans. The European Medicines Agency (EMA) has published new draft guidelines on registry-based studies ... providing data sources or infrastructure for post-authorisation evidence generation: ... EMA is hosting a virtual workshop on 19 October 2020 to present the draft guideline to key stakeholders. The final advice letter is endorsed by the PRAC and adopted by the CHMP through a written procedure before sending to the MAH/Applicant. If the same safety concerns apply to more than one medicinal product, the  relevant competent authority shall, following consultation with the PRAC, encourage the MAHs concerned to conduct a joint PASS (Article 10a(1)(a) of Regulation (EC) No 726/2004, Article 22a(1)(a) of Directive 2001/83/EC). Proposed changes to the product information as a result of the data within the PASS final study report can be submitted as part of the Article 107q procedure. What is the nature of the discussion meeting? 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. The responsibility to communicate with the rest of the participants in the joint study lies with the appointed contact person as per the specific contractual arrangements among MAHs. The Annexes of both the CHMP opinion as well as the CMDh position will be translated into all EU languages following an agreed time table. 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. Two SAWP members/alternates are appointed as coordinators for each scientific advice procedure. The PRAC will endorse the advice relating to PASS, and a Final Advice Letter will be issued. How do I prepare for a Discussion meeting? 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. The experience from the pilot phase showed an added value of pre-submission meetings and therefore it is proposed that all procedures would have such meetings to discuss the briefing document. EMA has recently revised a part of these Q&A concerning the procedure under which MAHs should submit post-authorisation measures and how they should structure the submission dossier. EMA's post-authorisation procedural advice document provides a printable overview in Q&A format of EMA's position on issues typically addressed with marketing authorisation holders. Following the discussion meeting with the MAH/Applicant, and further to the SAWP plenary discussion, the SAWP Coordinators issue a draft joint report for comments by the involved participants. At its next meeting following the PRAC recommendation, the CHMP or the CMDh, as applicable, will adopt an opinion or a position, respectively. Each procedure will have a named PRAC peer-reviewer appointed to provide product specific PRAC input. Protocols or synopses, SmPCs, Risk Management Plans and assessment reports pertinent to the topic should be annexed as appropriate. What type of question is expected to be raised for the concerned study protocols? Is a pre-submission meeting always expected or can the MAH/Applicant choose not to have one? The preliminary reports are discussed in the scientific advice plenary meeting and are made available to the involved Working Parties, Committees, and experts as appropriate. The update addresses recent changes regarding marketing and cessation notification requirements and the sunset clause. The SAWP Coordinators will then draft preliminary reports in response to the scientific advice or protocol assistance requests taking into account the timetable for evaluation of such requests.In addition to the SAWP coordinators and the joint PRAC SAWP delegate, a PRAC peer-reviewer is appointed to follow the procedure. If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation. 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. Article 107p. The final protocols for non-imposed PASS required by the PRAC can continue to be submitted to the PRAC as a Post-authorisation measure (PAM). 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. For centrally authorised medicinal products (CAPs) the change of the due date of the corresponding condition to the marketing authorisation (MA) will require a change to Annex II of the marketing authorisation via a variation application. User Guidance for Marketing Authorisation Holders (MAH) EMA/346582/2016 v. 2.15 Page 5/77 Version Date Changes applied Author 2.10 28/02/18 Updated to reflect changes introduced in v3.4. 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. Risk Management Planning & Mandated Post-Authorization Studies 8 PRA HEALTH SCIENCES 4 Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies EMA/623947/2012 5 The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). timetable EMA continue to monitor the presence of nitrosamine impurities in medicines, in co-operation with regulators from outside the European Union (EU), and to work with marketing authorisation holders to find rapid solutions to address any adverse findings. Could questions be asked about the choice of the adverse reactions of interest? ” for each language if all comments have been implemented or not. If issues which prevent the adoption of a recommendation are identified, the PRAC will adopt a request for supplementary information together with a deadline for submission of the requested data by the MAH and a timetable for the assessment of the MAH's responses. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. 1 Systematic reviews and meta-analyses of safety data should be considered as non-interventional PASS. The clock will be stopped until the receipt of the requested supplementary information. Does EMA expect all PASS studies to go through scientific advice? Feedback on whether questions can be validated as posed or reworded will be given at the validation stage. Where the proposed changes are not based on the data submitted within the final study report, these will not be considered and a variation will have to be submitted as appropriate to the relevant national competent authority. Translations of the adopted Annexes in EN and all other EU languages (and in Icelandic and Norwegian, if applicable) are to be provided electronically (in one Eudralink package if applicable) to the Member States (MS) contact Points for Translations and to the EMA procedure assistant for voluntary linguistic check. Scientific advice procedures for PASS will involve PRAC systematically at all the stages of the procedure. In case the PRAC recommends any regulatory action, i.e. All submissions should contain a cover letter and a duly completed eSubmission delivery file. 1051 calendar days after adoption of the CMDh position (see Question 10). They should only be included as an annex to the risk management plan (RMP), once they are endorsed by PRAC, at the next regulatory opportunity. 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. Depending on the type of outcome and whether an EC Decision is required (i.e. The revised product information of the product(s) concerned should be presented in English language in module 1.3. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. It provides a general guidance on the development, conduct and reporting for many FAQs. Scientific advice on safety studies is a voluntary procedure for Marketing Authorisation Holders (MAH) or Applicants, and complementary to existing ones. This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations. Draft protocols of non-interventional imposed PASS should be submitted as a separate document in module 1.8.2 of the common technical document (CTD). assessment team from the same member state) or appointed as the PRAC peer-reviewer for a specific scientific advice procedure. 2) Implementation plan revision 1. After a study has commenced, the MAH has to submit any substantial amendment to the protocol, before its implementation, for review and endorsement by PRAC. A letter of intent for scientific advice should be submitted to the Agency at the mailbox scientificadvice@ema.europa.eu together with a briefing document in accordance with published EMA scientific advice guidance and timelines. The MAHs are also strongly advised to liaise directly with the Member States in case of disagreement with any of the comments made or in case further clarification on some comments is required, and to reflect the outcome in “ The Agency encourages scientific advice on safety studies to further develop an integrated lifecycle approach in the advice on medicines across safety, quality, efficacy pre- and post-authorisation, and to support proactive pharmacovigilance planning, which is elaborated through the Scientific Advice Working Party (SAWP) with the Pharmacovigilance Risk Assessment Committee (PRAC) endorsing the scientific advice letters in the case of PASS protocols. Upon receipt of a technically valid application, the Risk Management Specialist (RMS) will perform the validation of the application content. In order to facilitate and accelerate the check of the implementation of the comments, the MAH should indicate in “ Scientific guidance on post-authorisation efficacy studies ENCePP Plenary Meeting, 22 November 2016 Presented by Kevin Blake D-SSD-CPN EMA . on how the fees are calculated and collected. Feedback on whether the MAH or Applicant's draft questions can be validated as posed or reworded will be given at the validation stage. This is known as the post-authorisation stage of the product lifecycle. Please see the published Applicants/MAHs are encouraged to request scientific advice (SA) from the Agency on specific aspects of PASS protocols, especially for complex or controversial issues or for innovative approaches or methodologies. In case of disagreement between a Member State and the MAH, EMA will not interfere in the translation process. Ready availability of relevant documents and references facilitates assessment. MAHs should translate for their products all relevant Annexes. Upon receipt of a technically valid application, the Risk Management Specialist (RMS) will perform the validation of the initial application (including format of the protocol). For NAPs, further guidance on implementing variation can also be found on the CMDh website (Question Answers, Pharmacovigilance legislation). QRD Form 2 EudraVigilance is also one of the main pillars of the European Risk Management Strategy , a joint effort between the EMA and NCAs to strengthen the conduct of pharmacovigilance in the EEA. Protocols and protocol amendments (Articles 107n-o). MGL c.149 Labor and industries.Numerous sections throughout this chapter apply to the hiring process. 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. the sections [to be completed on a national level] simply to be translated as 'to be completed on a national level'. timetable The revised protocol can then follow subsequent 60-day assessment procedures as per the timelines above until it is fully endorsed by the PRAC. NEW May 2017. The assessment under a 107n 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. 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. 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