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Jun 2, 2017

Widler & Schiemann Ltd. and Beijing Jingwei Chuanqi Medicines Service Ltd. start Joint Venture in China
WS China will be a joint venture together with our partner 3Audit

Beijing Jingwei Chuanqi Medicines Services Ltd, a GxP audit services company based out of Beijing, China, also known as 3Audit, with branch offices in several Chinese cities and Widler & Schiemann Ltd, a strategic Clinical Development Consulting Firm based out of Zug in Switzerland announced on May, 24th at the Annual DIA China Meeting in Shanghai the forming of a joint venture.

“This is a great day for both our companies”, says Dr. Peter Schiemann, Managing Partner at Widler & Schiemann. “We are complementing each other with our offerings and can now provide a broad variety of services to our clients in the Asia Pacific Region”.

“We see it is hard for our clients catching up with the pace of ICH and international standards in inspection and approval review”, says Mr. Xuliu Cai, President of Beijing Jingwei Chuanqi Medicine Services. “This brings an opportunity and challenge to China Pharma companies with ambition in innovative drug development, and sets high demands for quality management and oversight.”

As the leading service providers and consultancy firms in auditing and quality management, our joint Venture will accelerate the audit and quality management knowledge transfer to China Pharma companies, and help our clients to meet the demands of the latest reform in regulations.

China submits conditional application to join ICH
At DIA China Annual Meeting China Secretary Yuan Lin confirmed China’s application

The China Food and Drug Administration (CFDA) and U.S.-based nonprofit, multidisciplinary association the Drug Information Association (DIA) recently held a joint seminar on International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) standards. The CFDA’s International Cooperation Secretary Yuan Lin revealed that China has submitted an application for conditional access to the ICH. China has been engaged with exchanges in relation to amending ICH standards, and has already adopted around 20 such standards, including Good Clinical Practice (GCP) norms.

Also speaking at this week’s event, Dr. Theresa Mullin, Director of the Strategic Planning Office of the U.S. FDA's Center for Drug Evaluation and Research, and Dr. Barbara Kunz, DIA Global CEO, and director of the International Project Office of the Japanese Medicines and Devices Supervision Board, outlined coming ICH reforms, and the contribution of the DIA to ICH's global development. ICH is planning to expand its existing membership to involve more regulators around the world. The CFDA’s recent feedback documents in relation to drug approval norms revealed plans to move much more closely in synch with ICH norms, with the promise of synchronized European/U.S. development in future.

Read more online

EMA issues Draft Guideline on Serious Breaches
Breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

This guideline outlines the practical arrangements for notification of serious breaches of clinical trials authorized in the Europe Union / European Economic Area. It aims to provide advice on what should and what should not be classified as a serious breach and what must be reported. It does not include guidance related to urgent safety measures or other reporting obligations related to subject safety.

Consultation end date is the 22nd August 2017.

Read the pdf

No timeline at FDA for adoption of ICH E6 (R2)
Widler & Schiemann asked the USFDA as no information can be found on their homepage

ICH E6 (R2) will come into effect in Europe in June, as well as Switzerland, however, no information can be found on the FDA homepage on its implementation or effective date. Therefore we send an email to the FDA to find out whether there are any plans. The answer we received was as follows:

“… FDA plans to recognize/adopt ICH E-6 (R2) but the date at this time is unknown.”

Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in November 2017

The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analyzing suspected adverse reactions.

Read more online

East African Community looks to EMA as model for future regional agency
EMA and East African regulators met on 18-19 May 2017

As part of the European Medicines Agency’s (EMA) ongoing collaboration with African regulators, a delegation from the East African Community (EAC) visited the Agency on 18-19 May 2017. The goal of the two-day meeting was to gather information and experience to support the potential creation of a networking medicines agency for the EAC.

Read more online


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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 - -