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Jul 31, 2016

CFDA issues extensive DRR draft amendments
The China FDA invites comments on their latest revision of their Drug Registration Regulation

The China Food and Drug Administration (CFDA) this week issued a draft of revisions to the Drug Registration Regulations (DRR), seeking public feedback until August 26, 2016. Notably, preliminary analysis indicates that the revisions are extensive reducing the length of the current 2007 edition of the DRR to eight sections and 147 clauses from 15 sections and 177 clauses previously. The DRR is the key legal document underpinning drug registrations in China. An upgrade is necessitated by the changes in the definition of “novel” and “generic” drugs; the shift to take into account the product’s level of innovation and clinical advantage in selecting registration category; and the requirement for quality and efficacy evaluations between generic and originator drugs.

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The text of the new regulation is available in Chinese language only on the CFDA homepage.

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European Commission launches EU-U.S. Privacy Shield
A new framework for stronger protection for transatlantic data flow to build trust

On 2 February 2016 the European Commission and the U.S. Government reached a political agreement on a new framework for transatlantic exchanges of personal data for commercial purposes: the EU-U.S. Privacy Shield (IP/16/216). The Commission presented the draft decision texts on 29 February 2016. Following the opinion of the article 29 working party (data protection authorities) of 13 April and the European Parliament resolution of 26 May, the Commission finalised the adoption procedure on 12 July 2016.

The EU-U.S. Privacy Shield reflects the requirements set out by the European Court of Justice in its ruling on 6 October 2015, which declared the old Safe Harbour framework invalid.

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EMA to introduce Public Hearings
Vox Populi at EMA’s PRAC

Public hearings are a new tool allowing the European Medicines Agency (EMA) to engage with European Union (EU) citizens in the supervision of medicines and listen to their views and experiences. EMA is preparing to hold public hearings at its Pharmacovigilance Risk Assessment Committee (PRAC) from as early as the fourth quarter of 2016.

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EMA plans to revise guidance on first-in-human clinical trials
Comments invited on a concept paper on changes intended to support best practices

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper, which has been released for public consultation. Comments on the proposals should be sent to until 30 September 2016 using the form provided.

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