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Dec 31, 2017

 
The Team @ Widler & Schiemann wishes you a Happy New Year 2018!


Henk de Wilde joins Widler & Schiemann Ltd. as Managing Director
Henk de Wilde will join Widler & Schiemann Ltd. in Switzerland in January 2018

On January 1st 2018, our new Managing Director, Mr. Henk de Wilde, who will be responsible for our office in Switzerland and our business in the European Region joined Widler & Schiemann Ltd.

We are very fortunate and proud that Henk has joined us as he brings to our company a wealth of experience from the pharmaceutical industry as well as CROs. Henk will be working closely with Beat Widler in supporting projects with Key Clients.

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EMA adopts ICH guideline E17
ICH guideline E17 on general principles for planning and design of multi-regional clinical trials coming into effect in June 2018

With the increasing globalization of drug development, it has become important that data from multi-regional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and countries as the primary source of evidence, to support marketing approval of drugs (medicinal products). The purpose of this guideline is to describe general principles for the planning and design of MRCTs with the aim of increasing the acceptability of MRCTs in global regulatory submissions. The guideline addresses strategic program issues as well as issues that are specific to the planning and design of confirmatory MRCTs, and it should be used together with other ICH guidelines, including E5, E6, E8, E9, E10, and E18.

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Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
EMA and European Commission publish updated Q&As

The European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union (EU).

Companies are reminded to plan in advance for the situation that the United Kingdom (UK) will leave the EU on 29 March 2019 in order to avoid any impact on the continuous supply of medicines for human and veterinary use within the EU.

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New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER

The purpose of this guidance is to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA (21 CFR 314.101(d)) or a biologics license application (BLA) or supplemental BLA (21 CFR 601.2) for a therapeutic biological product regulated by CDER,2 and to underscore the importance of submitting a complete application to minimize the chance of a refuse-to-file (RTF) action by the FDA. In particular, this guidance focuses on the FDA’s policy for refusing to file an NDA under § 314.101(d)(3) when the NDA is incomplete because it does not on its face contain information required under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 314.50.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

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US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles
Draft Guidance for Industry and Food and Drug Administration Staff

The Food and Drug Administration (FDA) is committed to helping patients gain more timely access to new medical devices and to maintaining continued access to existing medical devices that are high quality, safe, and effective, by expediting their development, assessment, review, and surveillance, consistent with the Agency’s statutory mission to protect and promote the public health.1 By streamlining regulatory processes and removing or reducing unnecessary burdens associated with FDA regulatory activities, patients can have earlier and continued access to beneficial products.

Since the FDA Modernization Act of 1997 (FDAMA), Congress has directed FDA to take a least burdensome approach to medical device premarket evaluation in a manner that eliminates unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This draft guidance is intended to accurately reflect Congress’ intent by describing the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles.

We define “least burdensome” to be the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.

This concept applies to all products that meet the statutory definition of a device and throughout the total product lifecycle (premarket and postmarket).

FDA's guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. Throughout this guidance document, the terms we, us and our refer to FDA staff from the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) involved in device regulation.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

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Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation

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CFDA moves towards 60-day clinical trial reviews
China Food and Drug Administration shortens the review time on clinical trial applications

The stream of drug approval system reform notifications continues, the CFDA last week issuing concrete draft proposals to adjust the rules governing how drug clinical trial reviews are handled. In theory, the changes will see the CFDA’s clinical trial approval process more closely resemble U.S. FDA pathways. Key measures are as follows:

- Formal pre-filing meetings between drug companies and CDE reviewers will be required, with flexibility for companies carrying out multi-regional clinical trials coordinated with China to skip directly to a filing.

- A 60-day time limit will be applied to clinical trial reviews, starting from the CDE’s formal acceptance of a filing. From that point, if the CDE does not issue a rejection of the application or otherwise query the filing within 60 days, the applicant can assume approval and initiate clinical trials based on the submitted protocol.

- Meetings with CDE staff to be held ahead of the initiation of Phase II and III studies for discussion of clinical trial protocol.

- If any changes are required to the protocol, such as adding a new indication, the applicant can make a supplementary application that the CDE promises to review within 40 days.

The draft document represents a concerted step towards aligning China’s drug approval system with international norms, as promised in the string of announcements released in March and May this year, and following the CFDA’s accession to full membership of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in June this year.

Source: GBI (gbihealth.com)

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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 - info@wsqms.com - http://www.wsqms.com