Regulatory News

This newsletter provides information and insight regarding regulatory affairs for all aspects of medicines and medical device regulation.

The purpose with the newsletter is to facilitate the development of and avoid common pitfalls in different applications and thereby improve the review process. The newsletter is published periodically and cover topics such as:

• submissions (pre-authorisation and post-authorisation) – how to get them right the first time
• key issues – the inside track on emerging issues for the regulation of medicines


28 January 2020
New case management system at the Swedish Medical Products Agency; Status and updated information regarding Clinical Trial Regulation (Regulation (EU) No 536/2014); Make sure to separate EAN and 2D coding on packages; Corrections of the European Regulations on Medical Devices; Proposed changes in national medical device legislation; Withdrawal of marketing authorization due to unpaid annual fees - A reminder; Reporting shortages.

25 November 2019
Voluntary Harmonized Procedure (VHP) within clinical trials – clock stop during Christmas; The EU commission has approved new guidelines for Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMP); The joint pilot project for clinical trials according to Regulation (EU) 536/2014 will restart in Q1 2020 and will also include clinical trials of medical devices; New Q&A document; Call for review of nitrosamine impurities in medicinal products for human use; Conference on the European Pharmacopoeia; Newsletters on medical devices; The medical device database EUDAMED delayed; Withdrawal of marketing authorization due to unpaid annual fees - A reminder.

15 November 2019
Reduced capacity to answer calls 25-29 november.

26 September 2019
Getting ready for the new regulations on medical devices; Global public meeting on draft ICH guideline on clinical trials; How to report End of clinical trial – Annex III update 19 June 2019; New procedure for medical device serious adverse event reporting; Change of the process for the update phase of the assessment report for mutual recognition (MRP) and repeat-use (RUP) procedures; Withdrawal of marketing authorization for medicinal products; Simplified procedure for the submission of the letter of intent for Variation Worksharing; ICH guideline on General considerations for clinical studies; ICH guideline on optimisation of safety data collection; EMA Templates; Updated guidelines and other publications; Information published in English regarding package leaflets and labelling in Sweden; Clarification regarding expiry dates on packages for medicinal products bearing unique identifiers; Variation applications - Tips on how to minimize the risk for validation comments.

6 May 2019
Common European Single Submission Portal (CESSP) - Webinar; MPA as RMS; OTC in the eCTD; Requirements regarding exemption from charges when applying for clinical trials Pilot project for clinical trials; Submission of variations to the MPA – A reminder; Withdrawal of marketing authorization for medicinal products; Temporary or permanent stop of marketing; Changes in fee incentives for SME; Updated guidelines; Other publications from EMA; STARS, new EU funded initiatve.

24 April 2019
Welcome to the Pharmacovigilance Day in Uppsala.

7 March 2019
Exemptions for medicines to continue batch control in the UK after Brexit; National exemption for batch release in the UK - In exceptional cases for the Swedish market; Fees for Clinical Trials and Scientific Advice: Exemptions for Non-Commercial Actors Suspended.

28 February 2019
New Requirements for Safety Features on Packages for Medicines; Correct Identification of Medicines is Important for Patient Safety; Mandatory Use of eCTD and VNeeS from January 1st 2019; Clinical Trials: How to Report Change of Legal Representative, Sponsor, and/or Site for QP certification; Adverse Events Reporting in Medical Device Clinical Investigations; Updated Provisions and Guideline: Labelling and Package Leaflets for Medical Products; A Harmonized Approach to Assessment of Mock-Ups/Artwork; More about Safety Features; Guidance for medical device manufacturers related to the withdrawal of the UK from the European Union (“Brexit”).

25 January 2019
Guidance Related to the Withdrawal of the UK from the European Union; Also Shortages Caused by Brexit Need to be Reported.

4 December 2018
Presentations and Q&A from our Brexit meeting is now available; EU Ombudsman: How can the EMA improve its pre-submission activities?; Shortages shall be reported to the MPA.

9 November 2018
Welcome to Uppsala: Information about Brexit from the Swedish Medical Products Agency; Available Slots for New Marketing Authorisation Applications; Training Presentations on Active Substance Master File (ASMF) Work Sharing Procedure; Marketing Authorisation Holder (MAH) Transfer During an Ongoing Procedure; Delays Starting New Procedures for Variations; Preparing for Brexit - The Withdrawal of the UK from the European Union

20 March 2018
Legal status on the packaging of medicinal products; Publication of product information in PDF-format; EU eSubmission roadmap – Use of eCTD for all regulatory activities in European procedures (MRP/DCP) from 1st January 2018; The Risk Management Plan (RMP) template; Shortened renewals for generics in MRP/DCP; New management of Sunset Clause exemptions from October 2017; Alvedon 665 mg modified release tablet withdrawn

14 July 2017
In Sweden: Sale of Systemically Administered Antimicrobial Medicines is now Restricted to Prescription Only; New EU Medical Device Regulation - Information at the MPA; Brexit - Guidance Related to UK Withdrawal from the European Union; Updates from the CMDh; 'Anhydrous' Removed from the European Pharmacopoeia; Pharmacovigilance Changes; SME info day at the EMA: Supporting innovative medicines' development and early access

12 April 2017
Welcome to Regulatory News from the Swedish MPA; Definition of a Duplicate Application and the Fee Ordinance; Updated Flow Chart for Mutual Recognition Procedure (MRP) and Repeat Use Procedures (RUP); sPARs No Longer Translated into Swedish; Submission of Product Information in Swedish; DHPC (Direct Healthcare Professional Communication); Variation Applications Submitted due to PSUSA/00001499/201602, Gabapentin; eSubmissions Roadmap Updated; Education - Variation Applications



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