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Nov 2, 2016

Opening up Clinical Data on New Medicines
EMA provides Public Access to Clinical Reports

The European Medicines Agency (EMA) gives open access to clinical reports for new medicines for human use authorised in the European Union (EU).

Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said "Transparency is an essential component in clinical research. Its outcome – whether positive or negative – should be made publicly available. EMA's transparency initiative will make Europe a true front-runner with respect to release of data concerning clinical trials. It will create a bridge from now until the new Clinical Trials Regulation - which foresees additional milestones towards transparency, becomes applicable."

For every new medicine, citizens, including researchers and academics, will be able to directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing-authorisation applications. Clinical reports give information on the methods used and results of clinical trials conducted on medicines. EMA is the first regulatory authority worldwide to provide such broad access to clinical data.

Read more online

First comprehensive Overview of global Initiatives on Medicine Regulation published
Mapping aims to improve International Collaboration

The European Medicines Agency (EMA) has published an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The report lists all international projects and provides international regulatory agencies with comprehensive details on the number and scope of global initiatives that can support decision-making regarding future engagement, prioritisation and coordination.

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Public Consultations by EMA
ICH E11(R1) guideline

ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population

Comments should be provided. The completed comments form should be sent to by 13 April 2017

Read the pdf

Concept Paper on GMP

Comments should be sent to by end of December 2016

Read the pdf

CDER Drug Safety Priorities: Initiatives and Innovation
FDA publishes report on Drug Safety Programs and Milestones

CDER Drug Safety Priorities: Initiatives and Innovation describes a number of programs that help ensure the safety of drug products, depicting the extensive, interrelated, and cooperative nature of our drug safety enterprise, while also reporting on key safety milestones achieved over 2015 and to date in 2016.

If you are interested to understand the FDA’s thinking on Drug Safety, this is the publication to read.

Read the pdf

A useful reference: RQA’s linked in group
RQA’s linked in group provides a lot of useful information to its members

If you are a linked in member you can apply for membership in this group and get access to all of the information it provides.

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