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Aug 20, 2021

Commission Decision (EU) 2021/1240 of 13 July 2021 on the Compliance of the EU Portal and the EU Database for Clinical Trials of Medicinal Products for Human Use with the Requirements Referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council
On 31 July 2021 the published the EU commission decision of 13 July 2021 on the compliance of EU portal and EU database for clinical trials.

The EU portal and the EU database have achieved full functionality and meet the functional specifications, as referred to in Article 82(2) of Regulation (EU) No 536/2014.

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

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ICH Guideline Q13 on Continuous Manufacturing of Drug Substances and Drug Products
On 29 July 2021 the ICH published the Q13 draft guideline.

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. The principles described in this guideline may also apply to other biological/biotechnological entities.

It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products.

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Clinical Trial Information System (CTIS) - Sponsor Handbook
On 29 July 2021 the EMA announced the availability of the handbook to help clinical trial sponsors preparing for using CTIS.

The aim of the EMA CTIS Sponsor Handbook (“Handbook”) is to provide clinical trial sponsors representing pharmaceutical industry, SME, academia, research organisations and other clinical trial sponsor organisations with the information they need for getting ready for use of the Clinical Trial Information System (CTIS) when the Clinical Trial Regulation (CTR: Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via CTIS. CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation.

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Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis
On 28 July 2021 the FDA published the draft guidance. Comments may be submitted by 27 October 2021.

The purpose of this guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as an alternative to anti-rabies virus immunoglobulin (RIG) as the passive immunization component of post-exposure prophylaxis (PEP) for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal. This draft guidance is intended to serve as a focus for continued discussions among the Division of Antivirals, sponsors, the academic community, and the public. This guidance does not address the development of rabies vaccines, products to treat rabies, or mAbs for other indications. The recommendations in this guidance relate to studies to be submitted in support of a biologics license application (BLA) submission under section 351 of the Public Health Service Act (42 U.S.C. § 262) and implementing regulations at 21 CFR part 601.

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Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
On 23 July 2021 the EMA published the reflection paper on GMP and the responsibilities of MAHs.

This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission (EC) Guide to GMP (hereafter referred to as the ‘GMP Guide’) refers, in several places, to MAHs and their responsibilities in relation to GMP.

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Guideline on Quality Documentation for Medicinal Products When Used with a Medical Device
On 23 July 2021 the EMA published the guideline on product-specific quality aspects of a medical device.

This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004. This guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.

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Field Alert Report Submission: Questions and Answers
On 22 July 2021 the FDA published the final Q&A guidance on filed alert report submission for industry.

This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions.

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Guidance on Paediatric Submissions: Via eSubmission Gateway and eSubmission Web Client
On 19 July 2021 the EMA announced the availability of the guidance on paediatric eSubmssion.

It is mandatory for applicants to use the eSubmission Gateway / Web Client for all paediatric submissions to the Agency. Applicants should follow the guidance on paediatric submissions published on the eSubmission\paediatric submissions page.

EMA does not accept submissions that do not follow the published guidance on paediatric submissions, including using the correct submission channel.

Applicants should note that the xml delivery files for paediatric submissions changed in November 2020. An overview of changes is provided in the following presentation, with further information in an updated guidance on paediatric submissions below.

EMA advises applicants new to the eSubmission Gateway to submit their application well in advance of the targeted deadline.

The guidance outlines the main steps to take in preparation for submission and a list of documents required for the main types of paediatric submissions.

This document should be read in conjunction with other relevant guidance on content available on the EMA website, such as the European Commission Guideline on the Format and Content of PIP applications; Paediatric Medicines; Paediatric investigation plans: questions and answers; and the Paediatric Regulation.

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