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Fear-based Relationships Antithetical to Progressing Quality Systems, While Measurement is Key, CDER’s Woodcock Stresses at ISPE Metrics Forum

The principle that fear-based relationships are antithetical to progressing quality systems is pivotal as FDA reshapes its quality regulatory approach, CDER Director Janet Woodcock is stressing....

FDA/EMA QbD Parallel Assessment Q&A

In mid-December, FDA and EMA began publishing a series of joint question-and-answer documents that outline the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application. The first one covers the level of detail expected in a QbD submission. FDA and EMA will publish additional question-and-answer documents on other QbD-related […]

China and Taiwan Mutually Recognize Inspections

Chinese and Taiwanese Health Officials have agreed to cooperate on clinical trial regulation and to mutually recognize drug inspections.

Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally

The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in mid-July with the release of draft guidances on post-approval supplements and easily correctable deficiencies. Comments on the drafts are due by mid-September....

EDQM Signs Confidentiality Agreement with Taiwan FDA

In late May, EDQM signed a confidentiality agreement with the Taiwan FDA. The confidentiality agreement concerns the “certification of suitability to the monographs of the European Pharmacopoeia,” and includes communications about the quality assessment of APIs and excipients used in manufacturing as well as about GMP inspections of manufacturing sites.

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, […]

Hamburg Addresses Drug Quality Regulation During India Visit

In mid-February, FDA Commissioner Margaret Hamburg traveled to India to meet with government officials on quality and other regulatory topics. This visit included the signing of a “Statement of Intention” to clarify the points on which both countries will cooperate, such as: ● sharing of CGMP compliance and facility information, ● India observing FDA inspections, […]

International Dialogue Should Focus on Harmonizing Control Strategy Filings and CMC Change Requirements, Moheb Nasr’s Industry Experience Confirms

Moheb Nasr’s recent experience as a leader of global CMC strategy for GlaxoSmithKline (GSK) has reinforced his conviction that the international quality regulatory dialogue should focus on clarifying and harmonizing the filing expectations for the control strategy as a lynchpin in the advancement of the quality-by-design/continuous improvement paradigm....

US/Canada Regulatory Cooperation Council Addresses DMF, GDP and OTC Harmonization

At the end of January, over 240 industry representatives and US and Canadian government food and drug officials met in Washington, DC to review progress and provide direction to working groups dealing with the 29 initiatives included in the US/Canada Regulatory Cooperation Council’s Joint Action Plan.  Initiatives on harmonizing regulatory standards for drug master files […]

FDA and EMA Formalize Mutual Inspection Reliance Program

FDA and EMA have formalized a program for relying upon each others' facility inspection data beginning in January in an effort to better utilize agency resources and avoid duplicate work following two successful joint inspection pilots...
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