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Dec 31, 2016

ICH E6 R2 adopted by EMA
The new ICH E6 R2 guidance will become effective in the European Union on 14. June 2017

The CHMP (Committee for Medical Products for Human Use) adopted the new ICH E6 R2 guidance on 15. December 2016 to come into effect in the EU on 14. June 2017.

The addendum reflects the current situation but also summarizes the needs for clinical trials and was overdue long since. It pays tribute to the increased complexity in clinical studies in the light of limited resources, patient safety and data integrity.

Industry will have to prepare quickly for the new regulation, as it demands some significant changes to how clinical trials are conducted today.

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EMA hosts workshop on adaptive pathways
Broad range of stakeholder questions addressed

The European Medicines Agency (EMA) has hosted a workshop with stakeholders to discuss adaptive pathways, an approach to medicines development that aims to facilitate access to medicines that address patients’ unmet needs.

The adaptive pathways approach is not a new regulatory route but rather one that makes use of existing legislative and regulatory tools in a more efficient way. More details can be found on the EMA homepage:

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New Guidance on the Use of Electronic Informed Consent Q&A
FDA publishes new Q&A document on electronic IC

This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.

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Providing Post Marketing Periodic Safety Reports in the ICH E2C(R2) Format
New FDA Guidance on Periodic Benefit-Risk Evaluation Reporting

This guidance describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonisation (ICH)3 E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the U.S. periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR), to satisfy the periodic post marketing safety reporting requirements in §§ 314.80(c)(2) and 600.80(c)(2) (21 CFR 314.80(c)(2) and 600.80(c)(2)). This guidance also describes the procedures applicants should follow if they wish to submit a PBRER in place of a PADER, PAER, or PSUR.

The steps will differ, depending on whether or not the applicant has an approved waiver in place to substitute the PSUR for the PADER/PAER.

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CFDA issues new GCP Draft
China Food and Drug Administration solicits comments on new GCP regulation

The CFDA recently proposed revisions to the Good Clinical Practices for Pharmaceuticals (“GCP”), the most comprehensive revision in 13 years. The revisions are now open to public comments until January 31, 2017.

It’s notable that CFDA has rewritten all the articles of the current GCP, but these sweeping changes are not especially innovative, as most of the concepts and principles have already been addressed in the International Council on Harmonisation (“ICH”) GCP.

Overall, CFDA sets forth general principles of conducting clinical studies in China, as well as guidance of roles and responsibilities for the ethics committee, the investigator and the sponsor, as well as the requirements for protocol and investigator’s brochure.

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