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Dec 1, 2017

On November 15th, our new Managing Director, Ms. Xi Chen, who will be responsible for our office in Shanghai, China and our business in the APAC Region joined Widler & Schiemann Ltd. China. We are very proud that Ms. Chen has joined us as she brings to our company a wealth of experience from the pharmaceutical industry as well as CROs. She will be the main contact for our clients in the APAC region and take over managing the Shanghai office from Dr. Peter Schiemann with immediate effect.

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognize inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.

In June, the European Commission confirmed that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU. Today, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019.

The European Medicines Agency (EMA) has launched today 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 system makes it easier for marketing authorization holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.

The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines (collectively referred to as standards) that govern human subjects research in 130 countries, as well as standards from a number of international and regional organizations. This Compilation was developed for use by researchers, IRBs/Research Ethics Committees, sponsors, and others who are involved in human subjects research around the world.

Content experts from around the world, listed at the back of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered in this Edition. Four new countries are featured in the 2018 Edition: Algeria, Madagascar, Mali, and Saint Lucia. For the first time, this year’s Compilation includes a section on Social-Behavioral Research.

FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, and sometimes fatal diseases. These patients face unique medical challenges. Sometimes there isn’t an FDA-approved drug to adequately address the needs of a patient with a rare disease. Therefore, the agency takes new steps to enable more patients with unmet needs to get access to promising treatments prior to full FDA approval.