CHCUK News & Articles

Thailand Publishes its Data Protection Act

Thailand's Personal Data Protection Act, B.E. 2562 (2019) ("PDPA") has been published in the Government Gazette on 27 May 2019. Timeframe With very few exceptions, companies and organizations collecting, using, disclosing, and/or transferring personal data will have...

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India’s Medical Device Regulations

Substances used for in vitro diagnosis, medical device, mechanical contraceptives, disinfectants and insecticides and other notified devices in India are now regulated by the Medical Device Rules, 2017, which became effective from January 1, 2018. Prior to the...

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Use of FDA 1572 Forms in Spain

The Spanish Competent Authority (AEMPS) has joined the position of the other European Agencies (Denmark, Germany, Norway, Sweden and Switzerland) by releasing a statement on the 24th April 2019, announcing that the FDA1572 forms should not be signed by Spanish...

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Draft FDA Guidance – Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics

This draft FDA guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA...

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Which Real-World Research Design Is Best?: An Algorithmic Approach to Optimal Study Design for Outcomes Research

In contrast to clinical development, in which the randomized controlled trial (RCT) is the go-to study design, real-world research encompasses a broader array of designs from which to choose. There are retrospective approaches, including database analysis and manual...

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