WSQMS Homepage


Nov 4, 2019

Providing Regulatory Submissions in Electronic Format: IND Safety Reports
On October 29, 2019 FDA published this draft guidance for comment by December 30, 2019. This guidance only applies to IND safety reports for serious and unexpected suspected adverse reactions required under 21 CFR 312.32(c)(1)(i).

This draft guidance describes the electronic format sponsors will be required to use when they electronically submit to the FDA investigational new drug application (IND) safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 21 CFR 312.32(c)(1)(i). FDA is establishing the electronic format requirements described in this guidance under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will supersede the effective version of the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (“eCTD Guidance”) for the submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance (see section III., Scope of This Guidance). This guidance will not replace any requirements in the eCTD Guidance other than those relating to the submission of IND safety reports required under 21 CFR 312.32(c)(1)(i) that are within the scope of this guidance. This guidance also references several technical specification documents, which provide additional details regarding the format for electronic submission of IND safety reports to FAERS.

Read more online

Electronic Submission of IND Safety Reports Technical Conformance Guide
This Document supplements the following Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019).

This Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The Guide supplements the draft guidance for industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019), which implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for certain IND safety reports submitted to CDER or CBER.

Read more online

Biosimilars in the EU - Information guide for healthcare professionals
On October 29, 2019 EMA and EC updated the guide on biosimilars in the EU. This guide was first published in May 2017.

The European Medicines Agency (EMA) and the European Commission (EC) have developed information materials on biosimilar medicines to improve understanding of these medicines in the EU. They have published an information guide to provide reference information on the science and regulation underpinning the use of biosimilar medicines.

In addition, an information guide for patients published by the EC explains in a clear, unbiased way what biosimilar medicines are, how they are developed and approved in the EU and what patients can expect in terms of availability and safety. EMA and organizations representing patients contributed to the development of this guide. It is available in 23 official EU languages on the EC’s website.

Read the pdf

Dialogue with Chinese authorities on medicine regulation
On October 25, 2019 the Chinese National Medical Product Administration (NMPA) delegation visited EMA. The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals.

Topics for discussion between Dr. Shifei Chen, Deputy Commissioner of the Chinese NMPA, Guido Rasi, EMA's Executive Director, Andrzej Rys, Director responsible for Health Systems, Medical Products and Innovation at the European Commission’s Directorate-General for Health and Food Safety included good manufacturing practice (GMP) standards for active pharmaceutical ingredients, good clinical practice (GCP) standards, and the Commission’s strategic approach to pharmaceuticals in the environment.

Discussions were also held around establishing a common training curriculum focused on GMP and GCP standards, in cooperation with other international partners and the World Health Organization (WHO). In addition, EMA introduced the Chinese delegation to EMA’s role and activities in areas like inspection coordination, the evaluation and authorization of medicines, and safety monitoring.

Read more online

Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
On October 24, 2019 FDA posted this draft guidance for industry. Comments may be submitted by December 24, 2019

The draft guidance is being revised to describe the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes.

This guidance provides information on the implementation of section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs approved under section 505(c) of the FD&C Act and biological products approved under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).

Read more online

Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
On 21 October 2019, EMA updated the questions and answers. This update focuses on aspects relating to the implementation and applicability of the requirements of Regulation (EU) 2017/745 to medicinal products with an integral or co-packaged medical device.

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations.

This document has been produced to provide guidance to Applicants as regards aspects falling within the scope of the Agency’s activities and should be read in conjunction with the new medical devices Regulation (EU) 2017/745, and the new in vitro diagnostic medical devices Regulation (EU) 2017/746. The medical devices regulation (MDR) and in-vitro diagnostics regulation (IVDR) replace the three existing Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The Regulations entered into force on 25 May 2017; however, they will have a transition period to allow manufacturers, notified bodies and authorities to comply with the changes and will come into full application on 26 May 2020 for medical devices and 26 May 2022 for in vitro diagnostics.

Read the pdf

Drug Master Files (DMFs) Guidance for Industry
On 18 October 2019 FDA announced the availability of this draft guidance. Once finalized, this guidance will provide FDA's current thinking on DMFs. Comments may be submitted by December 12, 2019.

This guidance provides FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types of information as well (e.g., toxicology information, shared system REMS (risk evaluation and mitigation strategy)).

Read more online

Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
On 10 October 2019 European Commission issued the guidelines on GCP specific to clinical trials conducted with ATMPs

ATMPs are complex and innovative products that may pose specific challenges to the design and conduct of clinical trials. For example, manufacturing constraints and the short shelf-life of the product may require the implementation of tight controls on logistical arrangements to administer the product. Likewise, the mode of application may render very difficult the use of placebo controls and/or may require specific training. Additionally, the long-term effects of the product may require specific arrangements for long-term follow-up of the subjects. Moreover, it is recognized that it may not always be feasible to generate relevant non-clinical data before the product is tested in humans.

While the general principles of GCP set out in ICH Guidelines are applicable to clinical trials with ATMPs, in some cases, it may be necessary to adapt those to the specific characteristics of ATMPs (e.g. regarding retention of samples). The implementation of additional measures may also be necessary (e.g. traceability requirements for ATMPs that contain cells or tissues of human origin, follow-up of patients after end of the clinical trial, training on upstream intervention of subjects and/or administration procedures).

Read the pdf

EMA updated Inspections procedure
On 7 October 2019, the 1,000th good clinical practice (GCP) inspection requested by EMA’s human medicines committee (CHMP) and coordinated by EMA was carried out.

The 1000th GCP Inspections requested by CHMP and coordinated by EMA was performed at a clinical investigators site in Toronto (Canada) by inspectors from Austria and Poland. EMA has developed an infographic showing the numbers and geographical locations of the CGP inspections requested by CHMP.

The GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections carried out in the context of the Centralised Procedure.

These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier or by other information such as previous inspection experience.

Read more online


You receive this newsletter, because you have subscribed to it.
If you no longer want to receive this newsletter, you can easily leave the list at this Website.You can't view the images in this e-mail? Click here to open it in your browser.

Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - -