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Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

CDER’s Office of Surveillance Will Oversee Expanding FDA’s QA Assessment Capabilities and Reshaping Inspections

The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility....

EMA Releases New Guidance and Template for QP Declaration on GMP Compliance of API Manufacturers

In late May, EMA issued a guidance and a template for Qualified Person (QP) declaration of the GMP compliance of API manufacturers. The template is designed to standardize the format of the declaration and reduce the number of follow up questions. The agency recommends its use to “facilitate the validation of regulatory submissions and their […]

India Looks to Double Drug Inspectors

In mid-May, the Indian government announced plans to double the number of drug inspectors and install quality testing facilities at ports within the next three years as part of a $500 mil. plan to increase India’s drug regulatory capacity. The increase in its oversight program follows in the wake of recent compliance actions taken by […]

New US-EU Mutual Reliance Collaboration

As announced by Deputy Commissioner Howard Sklamberg in the FDAVoice blog in mid-May, FDA has plans to begin a “mutual reliance initiative” with the EU. The stated goal of the initiative is to increase the exchange “of information that is critical to making decisions that protect the public health.” In cooperation with EC and EMA, […]

Dep. Com. Sklamberg on Specialization Needs Within ORA

In an early May blog post on FDAVoice, Deputy Commissioner Howard Sklamberg emphasized that the shifting regulatory environment is creating an increased need for specialization within the agency’s Office of Regulatory Affairs (ORA), and noted the need for experts to contribute to that specialization.

Update Provided on Australia/New Zealand Agency

Australia and New Zealand’s regulatory agencies have provided an update on their progress in developing the Australia New Zealand Therapeutic Product Agency (ANZTPA). The combined agency will cover pre-market evaluation and assessment, product licensing, controls on manufacture, post-market monitoring and surveillance, and setting standards.

China Agrees to House More FDA Investigators

Chinese officials have cleared the way for FDA to station ten additional drug and device investigators in China. The FDA investigators will work out of the U.S. embassy and will have diplomatic privileges and immunities, Bloomberg reports.

EMA Launches New Version of EudraGMDP Database

EMA announced in December its launch of a new version of the EudraGMDP database which includes, among other changes, the publication of statements of non-compliance with EU GMPs, along with the list of companies that have been issued GMP certificates. [See IPQ January 28, 2013 for more on the revision.]

NSF-IPEC 363 GMP Standard Will Provide Risk-Based Approach for Auditing and Certifying Excipient Manufacturers

NSF International is working with the International Pharmaceutical Excipients Council (IPEC) and FDA to turn the IPEC excipient GMPs into a risk-based, certifiable standard with global applicability by the end of 2013, as recognition of the importance of excipient control continues to grow....
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