Regulatory roundup: Reviewing global changes in 2017

Will deregulation trump clinical trial patient safety?​​

The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.

Where’s the Brexit? UK clinical research industry charts path ahead of EU withdrawal​​

Industry leaders gathered at an Emergency Summit Meeting to discuss the implications of Brexit and the future of clinical research in the UK.

When, where, and how? Experts examine the current state of Brexit​​

The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose

PBOA: New user fee structure reduces CMO burden​​

President Trump has signed the FDA Reauthorization Act into law, reauthorizing four user fee agreements and reducing CMO burden, says PBOA.

How to prepare for ICH E6 R2 implementation​​

ICH E6 (R2) modernizes the ICH Good Clinical Practice (GCP) Guideline, which was implemented more than 20 years ago.

GCP 'Renovation' paper outlines revisions to ICH E8 and E6​​

ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.

Final Rule 'modernizes' protections for clinical trial participants​​

The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.

Safety implications of GCP loophole 'very concerning,' says IAOCR​​

IAOCR is lobbying for a change to current ICH-GCP Guidelines, which would help CROs “deliver strong, reliable trials efficiently.”

Compounding quality concerns: Legislation could 'fundamentally undermine' patient protections​​

Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).

Payment cap would ‘virtually eliminate’ the ability to conduct clinical trials​​

A proposed regulation in New Jersey demonstrates a lack of understanding regarding the clinical trial process and has clear collateral damage to research conduct in the state, ACRO testifies.

FDA outlines Cures implementation, touts in silico clinical trials​​

The US FDA has revealed its work plan for implementing aspects of the 21st Century Cures Act, including an investment in in silico tools for use in clinical trials.

FDA, EMA agree to share confidential info to further mutual recognition​​

The FDA and EMA have reached a new milestone during the process to implement mutual recognition of drug manufacturing facility inspections.

GMO regulations a ‘significant burden’ on gene therapy clinical trials​​

Gene therapy developers should start planning earlier, as EU GMO regulations are delaying clinical trial start-up across the bloc, according to a new expert position paper.

EMA technical group to address clinical report anonymization​​

The EMA has launched a technical anonymization group (TAG) that will help it develop best practices for clinical report anonymization following recent policy changes.

EMA proposal concerns: ‘Public health trumps commercial confidentiality’​​

Proposed amendments to the European Medicines Agency’s (EMA) access to documents policy have been criticized by medicines watchdogs, including not-for-profit Health Action International and Prescrire.

China FDA changes will speed up approval process, says CRO​​

Proposed changes to drug, medical device and clinical testing regulations provide stimulus for conducting trials in China, says CRO George Clinical.

CFDA: reform will continue, data forging to be 'severely punished'​​

The China Food and Drug Administration (CFDA) has become a member of ICH as it looks to continue advancing regulatory reform to improve the review process.

China now accepting clinical trial data from other countries​​

China has announced that it will now accept clinical trial data from other countries in a new guideline that aims to reform the management of clinical trials.

STA: Pilot program to enable CMO use in China is a 'huge opportunity'​​

The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.