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Health Canada to Release Inspection Findings

In late March, Health Canada announced that it would make its manufacturing facility inspection data public. The data will be presented in the form of an “inspection tracker” that will highlight the actions taken by Health Canada (request for quarantine, recall, or import restriction).

Import Alert on Two More Ipca Labs Indian Facilities

In late March, FDA placed two more Ipca Labs’ facilities on import alert – formulation plants located in Pithampur and Silvassa, India. The company’s API facility in Ratlam, India was placed under import alert in late January (see IPQ “News in Brief” January 31, 2015). Ipca received a warning letter from FDA

EU Medicines Agencies Network Strategy to 2020

EMA and the Heads of Medicines Agencies (HMA) released the “EU Medicines Agencies Network Strategy to 2020” draft in late March. The network strategy draft is organized into four themes: ● human health ● animal health and human health related to veterinary medicines ● optimizing the operation of the network, and ● the global regulatory […]

Comment Request on Drug Manufacturer Registration

FDA announced the opening of a comment period on the requirements for drug establishment registration and listing set out in section 510 of the FD&C Act. The comment period ends May 22.

Chinese API Firm Found Non-Compliant

Following from an inspection in late January, the French National Agency for Medicines and Health Products Safety found Huzhou Sunflower Pharmaceutical to be non-compliant with GMPs. Twenty-seven deficiencies were observed, with those defined as critical or major being: ● particle contamination ● disposal of quality documents ● deficient water system ● multiple Certificates of Analysis […]

EU Excipient GMPs Guideline

The European Commission (EC) released a final risk assessment guideline on GMPs for excipients in late March. The guideline points to ICH Q9 for basic principles and goes on to emphasize the need for focus on impurities risks as well as excipient traceability.

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 […]
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