ema post authorisation guidance

The guideline is primarily aimed at marketing authorization applicants and holders planning to conduct registry studies in the pre- or post-marketing authorization phase. describes practical aspects for the implementation of the new legislation and the operation of the E U medicines regulatory network. Upon receipt of a technically valid application, the Risk Management Specialist (RMS) will perform the validation of the application content. Products which received CMA/AEC by European Medicines Agency (EMA) up to 1 December 2016 were identified and matched with corresponding NICE decisions issued by August 2017, the status of which was then traced to August 2019. MGL c.149 Labor and industries.Numerous sections throughout this chapter apply to the hiring process. The use of key words in the subject line will help the Agency allocate your query to the correct person. Each procedure will have a named PRAC peer-reviewer appointed to provide product specific PRAC input. 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. In case of a joint PASS (i.e. Protocols or synopses, SmPCs, Risk Management Plans and assessment reports pertinent to the topic should be annexed as appropriate. the sections [to be completed on a national level] simply to be translated as 'to be completed on a national level'. For joint studies, the contact point of the marketing authorisation holders or consortium may be contacted for financial purposes. 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. Information about post-authorisation activities completed prior to 31 December 2020 will remain available on the EMA website. Guidance to avoid Nitrosamine Impurities: European Medicines Agency’s (EMA) issues guidance to avoid Nitrosamine in human medicines. whether at the moment of the submission there are sufficient certainties about the status and the objectives of the study. Depending on the type of outcome and whether a EC Decision is required (CHMP opinion or CMDh position by majority), the timelines for the translation process vary depending on the need for a linguistic review as illustrated below: Translations of the adopted Annexes in EN and in all other EU languages (and in Icelandic and Norwegian) are to be provided electronically (in one Eudralink package if applicable) to the How do I prepare for a Discussion meeting? Of note, products that are not involved directly in the procedure (i.e. Such studies should be submitted to the National Competent Authority (NCA) of the Member State in which the study is conducted, who will perform the assessment nationally. European Medicines Agency - EMA organises a second public meeting about the new COVID-19 vaccines. 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. Post-authorisation obligations, including specific obligations, Annex II conditions, additional pharmacovigilance activities in the RMP (MEA), legally binding … Post-Authorisation; Guidance Documents ... (ICSRs)' (EMA/H/20665/04/Final Rev. 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. SAWP will report to PRAC at each phase of the procedure. 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. 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. 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. In case of a procedure where several MAHs are involved, EMA will coordinate the translation process by approaching the MAHs individually and provide the timelines accordingly. PASS 107 submissions are available to the NCAs via the Common Repository. How do I apply for scientific advice on a PASS protocol? For CAPs, the PRAC Rapporteur will be the one already appointed for the product. For clinical trials, MAHs should follow the instructions in volume 10 of the rules governing medicinal products in the European Union (EU). EMA provides useful guidance on the submission of post-authorisation data on the questions and answers (“Q&A”) published in EMA’s website. 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. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. For imposed PASSs, the PRAC assesses the study protocol and the outcomes of these studies as given in the final study report. They include non-imposed studies that are requested in risk management plans. 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. Following the pre-submission meeting and validation, an amended electronic final package is submitted and circulated to the appointed coordinators and experts in line with agreed timelines. 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. The requirements for submission and assessment of protocols and final study reports for non-interventional imposed PASS: Before a non-interventional imposed PASS is conducted, the marketing authorisation holder(s) (MAH(s)) have to submit a draft protocol for review and endorsement by PRAC. format, layout and margins). guidance Can a draft PASS protocol be submitted for scientific advice although the marketing authorisation application is still under assessment? This is without prejudice to the provisions laid down in Article 107n of Directive 2001/83/EC for protocols of non-interventional imposed PASS to be assessed and endorsed by the PRAC. The MAH will receive the adopted timetable together with the request for supplementary information. 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 … For technical queries related to the submission please contact us through the EMA Service Desk portal. Protocols and public abstracts of results of imposed non-interventional PASS are publicly available in the EU PAS Register on the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) website. For category III studies, there is no legal obligation for companies to submit the protocol to the PRAC. The European Medicines Agency (EMEA) has released an updated post-authorization guidance. Scientific advice on safety studies is a voluntary procedure for Marketing Authorisation Holders (MAH) or Applicants, and complementary to existing ones. 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). The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. Article 107p. for many FAQs. 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. EMA fees query form This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. Feedback on whether questions can be validated as posed or reworded will be given at the validation stage. In case national variants of a study protocol are necessary to ensure the appropriate implementation of the study requirements to the specificities of national law, they should be submitted in the form of a regional appendix to the main protocol. A post-authorisation safety study (PASS) is defined in Article 1(15) of Directive 2001/83/EC as “any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures”. 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). 1 Systematic reviews and meta-analyses of safety data should be considered as non-interventional PASS. Please note that the advice provided within this pilot is without prejudice to any national requirement regarding the PASS protocols that might be in place is some Member states. The EMA highlights in the guidance document that the … 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. A further PRAC peer-reviewer is appointed to provide additional product specific PRAC input. The update addresses recent changes regarding marketing and cessation notification requirements and the sunset clause. 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. Day 1 – 14 (1 to 14 days after position): MAH translates the adopted Annexes in all other EU languages based on the EN provided version. Guide on What is the nature of the discussion meeting? The guidance is based on Commission Implementing Regulation No 520/2012 of 19 June 2012. Is a pre-submission meeting always expected or can the MAH/Applicant choose not to have one? Supplementary information may be requested by the RMS in order to finalise the validation. The revised protocol can then follow subsequent 60-day assessment procedures as per the timelines above until it is fully endorsed by the PRAC. are available. the category III PASS. The timelines of the progress reports for a given study should be pre-specified and indicated in the protocol. In order to facilitate and accelerate the check of the implementation of the comments, the MAH should indicate in “ In view of the short timeframe for finalisation of the translations and in order to optimise the quality of the translations, the MAHs are strongly advised to prepare for the translation process well in advance in the pre-opinion / position stage, i.e. For centrally authorised products, if you cannot find the answer to your question in this Q&A when preparing your application, please contact the Risk Management Specialist (RMS) assigned to your product. 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. 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. Marketing and cessation requirements involve informing the agency when a product is placed on or taken off of the market. For pre-submission queries that are not covered by this guidance please submit your query using the following web form. 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. 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 Agency will inform the MAH of the outcome of the validation, the procedure number and procedural The purpose of the information in PASSs is to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making. Yes, in accordance with the Agency's Fee Regulation1 and its corresponding Implementing Rules2, fees will be levied on MAH/Applicants seeking scientific advice on PASS protocols. 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. Further guidance on PASSs is available in: The Agency publishes the protocols, abstracts and final study reports of PASSs in the EU post-authorisation study (PAS) register hosted on the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) website. A RMP update can also be submitted with a final PASS study report for single centrally authorised medicinal product or a mixture of CAPs belonging to the same global marketing authorisation (GMA) when the changes to the RMP are a direct result of data presented in the study report. 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. Depending on the type of outcome and whether an EC Decision is required (i.e. Following experience gained from the scientific advice PASS pilot phase, scientific advice is encouraged to be sought for non–imposed PASS i.e. The format of non-interventional imposed PASS protocols and final study reports (Articles 107n-q of Directive 2001/83/EC) is provided in Annex III of Commission Implementing Regulation (EC) No 520/2012. The PRAC Rapporteur for a specific product is involved through either the SAWP coordinators (i.e. 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. EMA publishes the outcomes of final study results of non-interventional imposed post-authorisation safety studies (PASS) for NAPs on the EMA website. ” in the published scientific advice guidance. What is the format of the briefing document? A track-changes version shows the latest updates. Scientific advice is a voluntarily procedure and it is the choice of the MAHs or Applicants to submit scientific questions related to PASS / PASS draft protocol for scientific advice. question & answers as published in the post-authorisation guidance for access to the hyperlinked . and to the EMA procedure assistant. The rules governing non-interventional imposed PASS are set in Articles 107n-q of Directive 2001/83/EC. Figure 1: Overview of scientific advice procedure on PASS. However, some MAH/Applicant can choose not to request one. The latest PDF letter of Intent form provided on the EMA scientific advice website should be used. For joint studies it is of particular importance to accurately reflect in the cover letter the full list of medicinal products and MAHs concerned by the joint study (the eSubmission delivery file should list all the concerned medicinal products), as this will define the scope of the procedure, directly affecting the calculation of fees payable to EMA. How do I prepare for a Discussion meeting? Is a discussion meeting with the MAH/Applicant during the procedure always expected? Final study results – Article 107q procedure. In case of incomplete or incorrect data in the web form, the request may not be processed. 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. Specifically scientific advice can be sought for the selection of adverse reactions of interest. The outcomes of imposed non-interventional PASS final study results assessments for active substances found only in centrally authorised medicines are published as part of each medicine's European public assessment report (EPAR). 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. Dossier requirements for referral, ASMF and NAP submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device. The recently updated EMA page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation safety studies (PASSs). All submission for CAPs and NAPs sent to EMA via eSubmission Gateway/Web Client will be considered delivered to the PRAC Rapporteur and all members of the PRAC. 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. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee ( PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing … A Letter of Intent should be sent by email to scientificadvice@ema.europa.eu in advance of the anticipated start of the procedure. The MAH/Applicant may also propose in writing to the Agency additional points for discussion that are not part of the adopted list of issues and submit these in writing ahead of the Discussion meeting. When those are requested to be submitted, appropriate procedures should be followed (i.e. Post-authorisation The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. 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. This is known as the post-authorisation stage of the product lifecycle. 2. 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. 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 post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures. An EU competent authority may impose a non-interventional PASS, either as a condition of marketing authorisation (category 1) at the moment of granting the marketing authorisation or in the post-authorisation phase, or as a specific obligation in a conditional marketing authorisation or a marketing authorisation under exceptional circumstances (category 2). full. scientific advice template Will fees be levied for scientific advice provided for PASS protocols? QRD Convention 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. 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. These questions and answers (Q&As) provide an overview of the European Medicines Agency's (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. The PRAC Rapporteur for a product will be systematically involved either through the SAWP coordinatorship or as PRAC peer-reviewer roles to ensure continuity across procedures through the lifecycle of the products. The MAH(s) will implement the required changes. 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). 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. In case of disagreement between a Member State and the MAH, EMA will not interfere in the translation process. All submissions should contain a cover letter and a duly completed eSubmission delivery file. For NAPs, a PRAC Rapporteur will be appointed upon receipt of a PASS final study report. 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. Disagreements should be solved directly with the concerned Member State. 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. It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Expertise in pharmacoepidemiology needed to evaluate PASS protocols, is available through the extension of the SAWP currently to 2 joint SAWP - PRAC delegates who can also act as SAWP coordinators for a specific scientific advice product procedure. See link here. 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. CHMP opinion or CMDh position by majority/ consensus), the implementation of the outcome of a non-interventional imposed PASS results vary as illustrated in the table below. information. 1051 calendar days after adoption of the CMDh position (see Question 10). What is the role of the PRAC within the scientific advice procedure for PASS protocols? In this case no stand-alone RMP variation is necessary. For any remaining question, the dedicated EMA Two SAWP members/alternates are appointed as coordinators for each scientific advice procedure. This person will be the primary contact point on all interactions with EMA and will receive the documentation relevant for the procedure. 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. 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