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Oct 18, 2019

 
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit
MHRA updated this guidance on October 11, 2019. Pharmacovigilance system requirements if there is a no-deal Brexit.

The MHRA has updated the Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit by adding new section about the temporary exemption in relation to the pharmacovigilance system master file and adding information about requesting a UK PSMF number via the MHRA Submissions portal.

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Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry
On October 9, 2019 FDA announced the availability of the final guidance for industry. This guidance describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.

The purpose of this guidance is to describe an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), nonsignificant risk (NSR), or exempt from investigational device exemption (IDE) requirements. If the IVD in the trial is determined to be SR in the streamlined process, the sponsor may need to submit an IDE to the appropriate center (Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER)) in addition to submitting an investigational new drug application (IND) to the appropriate center (Center for Drug Evaluation and Research (CDER) or CBER). FDA encourages sponsors to use the streamlined process described in this guidance when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review.

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PRIME (priority medicines) Eligibility Requests
On October 4, 2019 EMA announced deadlines for submission and timetable for assessment in 2020

PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.

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EU Clinical Trial Regulation Update
On October 4, 2019 EMA updated the Clinical Trial Regulation (No 536/2014) in the EU

Update: In October 2019, EMA's Management Board endorsed the six-monthly monitoring report on the development of the Clinical Trial Information System (CTIS), which assesses the performance of the IT supplier against agreed key performance indicators. The Board agreed that actions proposed in the report should be further developed, for example improving the quality of the work delivered by the supplier and selecting the critical items needed for audit, as well as extending the monitoring period for at least three releases.

The product owners validated the first release developed in the agile, iterative delivery in September 2019, confirming that all 79 items had been delivered.

The release enhanced CTIS functionalities for the submission of clinical trials and the assessment process, user management and included other general improvements.

The product owners will begin to carry out an operational assessment of the system to identify critical business blockers, in order to enable EMA's Management Board to consider the timing of the audit of the system.

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Investigational Enzyme Replacement Therapy (ERT) Products: Nonclinical Assessment
On October 1, 2019 FDA published this guidance for comment purposes only. Submit comments by January 2, 2020.

This guidance provides consistent recommendations for nonclinical studies to expedite developments of ERT products used to treat these rare, life-threatening conditions, especially in pediatric patients.

The purpose of this guidance is to help sponsors design and conduct nonclinical studies during development of investigational ERT products. Specifically, this guidance describes the FDA’s current thinking about the substance and scope of nonclinical information needed to support initiation of clinical trials, ongoing clinical development, and marketing approval for investigational ERT products.

This guidance is intended as an adjunct to the ICH guidances for industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (January 2010), M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals — Questions and Answers (February 2013), and S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012).

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FDA’s Top GMP Inspection Findings for Fiscal Year 2019
Drugmakers continue to stumble at the same old hurdles: failure to document quality unit responsibilities and procedures

An FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles.

Failure to document quality unit responsibilities and procedures was once again the top citation in the agency’s Form 483 reports. It’s been the top citation for over a decade — often by a wide margin.

This year, the agency logged 185 instances of the violation, 50 more times than the second most frequent GMP lapse, which was failure to thoroughly review unexplained discrepancies or batch/component failures to meet specifications. The agency observed that failure 135 times compared to 107 in 2018, moving it up from third to second place.

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