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Oct 21, 2020

Estelle Chao Promoted to Managing Director APAC at Widler & Schiemann Ltd. Shanghai
On 19 October 2020 WSQMS Managing Partner Dr. Peter Schiemann announced the promotion of Estelle Chao to Managing Director APAC with immediate effect.

Estelle Chao, MBA, joined Widler & Schiemann (WSQMS) Shanghai Ltd. in 2018 as principal consultant for the Asia Pacific region. Widler and Schiemann has experienced significant growth as a direct result of her strategic management experience, customizing and optimizing projects for a wide variety of Chinese pharma/biotech/start up companies; driving efficiency and coordinating innovation-focused planning to prioritize ROI management and implement new pathways to address market access/penetration models and leverage third-party engagement.

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WSQMS Managing Partner Dr. Beat Widler Key Speaker at 20-year Anniversary of Swiss Centers China in Neuchatel
On 16 October 2020 the Swiss Centers China celebrated its 20-year anniversary in Neuchatel Switzerland.

The Swiss Centers Foundation celebrated its 20-year anniversary on October 16 in Neuchatel. Over twenty years, Swiss Centers has served more than 350 companies in China.

As a member of the Swiss Centers China, WSQMS Managing Partner, Dr. Beat Widler, was invited to speak at their 20th year anniversary. During his presentation, he stated that WSQMS entered the Chinese market because the country is undergoing a fundamental transformation in the health sector resulting in an impressive growth of start-up companies that are developing innovative health care solutions and WSQMS is uniquely positioned to support foreign companies expanding into the Chinese market who need help navigating the complex Chinese regulatory waters. In major markets such as the US and EU, WSQMS helps clients understand the regulatory landscape by setting up the infrastructure that will withstand the scrutiny of Competent Authorities in those regions.

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Updated IRIS Guide for Applicants
On 15 October 2020 the EMA updated the IRIS guide on how to create and submit scientific applications for industry and individual applicants.

IRIS is a secure online platform for handling product-related scientific and regulatory procedures with EMA.

This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application for a scientific procedure (e.g. orphan designation application, scientific advice, or ITF briefing meeting request) and related activities.

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Testing for Biotin Interference in In Vitro Diagnostic Devices
On 15 October 2020 the FDA announced the availability of the final guidance for industry.

FDA is providing recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians. The recommendations apply to IVDs, including devices that are licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) and used in donor screening, that use biotin technology. This guidance finalizes the draft guidance of the same title dated June 2019.

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Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
On 15 October 2020 the FDA announced the availability of the final guidance for industry and FDA staff.

Nitinol is a commonly used material in the medical device industry. Device manufacturers have used nitinol’s unique properties (i.e., pseudoelasticity and shape memory behavior) to design innovative medical devices that would not be possible with conventional materials. Nitinol has been used extensively in cardiovascular devices such as stents, heart valves, guidewires, and vena cava filters. The use of nitinol in other device areas is growing, particularly for products intended for use in minimally invasive procedures. The thermomechanical behavior and processing sensitivity of nitinol raises special considerations when compared to conventional metals such as stainless steel, titanium, or cobalt-chrome alloys. Due to the unique properties of nitinol, the Agency has developed this guidance to provide FDA’s current thinking on technical considerations specific to devices using nitinol. The recommendations in this document should be evaluated in conjunction with the intended use and technological characteristics of your device and any relevant device-specific guidances.

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Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
On 15 October 2020 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted until 15 December 2020.

FDA developed this draft guidance to propose select updates to FDA’s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. The existing guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,’” (2016 Biocompatibility Guidance) remains in effect, in its current form, until this draft guidance is finalized. The proposed sections are intended to add or supersede applicable sections of the 2016 Biocompatibility Guidance after FDA considers public comment to this draft guidance. The sections of the 2016 Biocompatibility Guidance that are not affected by this select update will not be substantively changed and will remain in effect.

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Questions and Answers on Data Monitoring Committees Issues
On 8 October 2020 the EMA published the Q&A document on DMC issues.

The aim of this question-and-answer (Q&A) document is to supplement the Committee for Medicinal Products for Human Use (CHMP) Guideline on Data Monitoring Committee (EMEA/CHMP/EWP/5872/03 Corr) by providing clarification on (i) the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle, and (ii) the responsibilities for implementing DMC decisions. This Q&A document should be read in conjunction with this guideline using the same definitions and considerations contained therein.

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Checklist for Annual Updates for Parallel Distribution
On 8 October 2020 the EMA announced the availability of the guidance for industry.

The EMA recommends that this checklist is used in advance of submission of an annual update for parallel distribution. The company should be able to answer “Yes” to every item listed in the checklist unless a specific point is not applicable (“n/a”) to the application in question.

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MHRA Guidance on the Licensing of Biosimilar Products
On 7 October 2020 the MHRA published the open consultation document.

The purpose of this guidance is to provide developers of similar biological medicinal products (also known as biosimilars) with a clear outline of the requirements for biosimilar products in the UK.

Applicants should also consider the principles contained within the Committee for Medicinal Products for Human Use (CHMP) guidelines. This UK guidance contains some revisions to these CHMP guidance documents, to be implemented at the end of the transition period (1 January 2021).

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Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 7 October 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 7 December 2020.

This guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to follicle-stimulating hormone and estradiol), in breast cancer clinical trials. The issues of fertility and fertility preservation when treating premenopausal women with breast cancer are outside the scope of this guidance and are not addressed.

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EMA Updated Clinical Trial Regulation
On 5 October 2020 the EMA announced that the audit of the clinical trial information system (CTIS) will commence in November 2020.

The Clinical Trial Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralized EU portal and database for clinical trials foreseen by the Regulation. The CTIS's go-live date has been postponed due to technical difficulties with the development of the IT system.

The Management Board noted the progress in the development of the CTIS audit version which is on schedule for audit starting in November 2020. The first meetings with the independent audit team have taken place in preparation for the audit.

The group responsible for prioritizing all outstanding issues to the CTIS governance and matching the items remaining after the audit to the capacity available before and after go-live has been established and has made good progress. This group includes representatives from Member States and sponsors, as well as EMA and the European Commission. For the purpose of the prioritization exercise, as a working assumption, the go-live date of CTIS remains December 2021.

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Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment
On 1 October 2020 the FDA announced the availability of the final guidance for industry.

This guidance is intended to help sponsors develop drugs for treatment of opioid use disorder (OUD). This guidance addresses clinical endpoints acceptable for demonstrating effectiveness of such drugs. This guidance does not address the development of drugs intended only to provide symptomatic relief of opioid withdrawal.

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