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Regulatory Approach to Manufacturing and Control of Cell/Gene Therapies Draws International Discussion

Regulators around the world have been taking the opportunity at recent international forums to benchmark on their respective efforts to create a viable framework for regulating the manufacturing and control of cell/gene/tissue therapies and to consider harmonization possibilities....

WHO Report on Suspect Medical Products

WHO issued a report in late March on a meeting held in October to discuss “substandard/spurious/falsified/counterfeit medical products.” The report includes recommendations for health authorities on strategies for detecting and dealing with suspect and substandard medicines, as well as the prioritized actions member states are taking to prevent their production and distribution.

MHRA Data Integrity Expectations

MHRA updated its guidance on data integrity definitions and expectations for the pharmaceutical industry in mid-March. The guidance is meant to complement the EU GMP standards available in Eudralex. The update provides clarifications to the text following high levels of interest after its publication in late January.

New MHRA Compliance Report Guidance and Template

MHRA updated its compliance report guidance and the template for that report in mid-March. The report is now separated into a “Pre-Inspection Compliance Report” and an “Interim Compliance Report.”

CDER Safety Research Interest Group Report

The CDER Safety Research Interest Group (SRIG) released a report on identifying drug safety-related regulatory science needs and priorities for the agency in mid-March. Included among the seven areas named was improving product quality and design. The other six were: ● improving access to post-market data ● improving risk assessment strategies ● evaluating risk communication […]

Advanced Therapy Classification System on Regulatory Front Burner in Europe as Product Wave Builds Globally

As the wave of highly diverse cell/tissue/gene therapies under development continues to build globally, establishing a viable and mutually agreed upon classification system has become a top regulatory priority....

Comment Extension on cGMPs for Combination Products

The comment period on FDA’s draft guidance on cGMPs for combination products has been extended until April 23. The draft was issued in January (IPQ “News in Brief” January 27, 2015). The Regulatory Affairs Professional Society (RAPS) in conjunction with FDA held a workshop to discuss the new draft guidance and collect industry feedback on […]

Australia’s Reasons for Drug Application Rejection

TGA issued version 1.5 of its Australian Public Assessment Report (AusPAR) Guidance in mid-March. The AusPAR, published on the TGA website, includes information on the outcome of the evaluation process and the rationale for the decision to accept or to reject drug registrations.

Consent Decree Entered Against Specialty Compounding

In mid-March, FDA announced that a consent decree had been reached with Specialty Compounding based on the agency’s inspection findings of bacterial contamination in 2013. Under the decree the company is prohibited from manufacturing or handling sterile drugs. [For an in-depth analysis of FDA inspection findings at sterile compounding pharmacies see IPQ April 14, 2014.]

Public Docket on Compounding

FDA opened a public docket on compounding in early March. The docket is designated to receive comments, research, and information that is not specific to other compounding-related dockets. [For more on compounding developments and guidance related to the implementation of the 2013 Drug Quality and Safety Act see IPQ January 23, 2014.]
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