Searching Content by Hannah Kerr-Peterson from Arnold & Porter ordered by Published Date Descending.
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MHRA's Updated Guidance On A Hard-Brexit
As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...
16 Jan 2019
Update To ABHI Code Of Practice
The Association of British HealthTech Industries (ABHI) has this week published an update to their Code of Ethical Business Practice for the recently rebranded "health technology" sector.
10 Aug 2018
MedTech Europe Requests Extension To The Transition Period For The MDR
Last week, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the European Commission ...
European Union
8 Aug 2018
Update On The EMA's Policy On Publication Of Clinical Data
In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency's relocation...
United States
25 Jul 2018
Update To The EMA's Position On Access To Documents
The Public Access Regulation seeks to strike a balance between the desire for increased transparency of decision-making bodies and the importance of protecting specified public and private interests
European Union
10 Jul 2018
Launch Of The EMA's Orphan Designation Portal
Access to the database is limited to those with EMA accounts, and currently, users are only able to access information about their own products.
United States
27 Jun 2018
Update On The EU Clinical Trials Portal And Database
While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months ...
United States
18 Jun 2018
Commission Survey On National Penalties For Breach Of Falsified Medicines Rules In EU Member States
Article 118a of Directive 2001/83/EC requires Member States to lay down "effective, proportionate and dissuasive" penalties for those who are involved in the manufacturing, distribution, brokering, import and export...
European Union
12 Feb 2018
New Guidelines On GMP For Advanced Therapy Medicinal Products
The guidelines are not intended to place any restraint on the development of new technologies.
European Union
28 Nov 2017
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