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TGA joins EDQM’s CEP Assessment Process

EDQM announced in late June that its CEP Steering Committee has accepted the request from Australia’s Therapeutic Goods Administration (TGA) to actively participate in the assessment of applications submitted by manufacturers desiring a CEP. TGA has been accepting CEPs approved by EDQM for the past few years.

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.

Annual Meeting of the National Pharmacopoeia Authorities (NPA) of the Ph. Eur.

In late May, the annual meeting of the National Pharmacopeia Authorities (NPA) of the European Pharmacopoeia took place in London. According to the EDQM press release, following the event, the main topics discussed were: ● the implementation strategy for the future ICH Q3D guideline on elemental impurities ● current quality topics that have a potential […]

FDA and PANDRH Begin Work on Regulatory Competencies

In late May, FDA and the Pan American Network for Drug Regulatory Harmonization (PANDRH) began developing a set of regulatory competencies by which to drive regulator training. Another objective of the collaboration will be to analyze data from evaluations of regulatory systems in the region to decide on future activities and benchmark success.

USP Proposes New Standards for Organic Impurities

Appearing in the May-June 2014 issue of the Pharmacopoeial Forum (PF) were a draft chapter proposal and a draft chapter revision updating USP’s coverage of organic impurities. The revision of general chapter <1086> on drug substance/product impurities and the proposal for the addition of a chapter <476> on drug substance/product organic impurities, which will align […]

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, […]

In mid-May, EDQM published a draft of its first finished product monograph, covering sitagliptin phosphate tablets, for comment. The monograph is available in the online forum Pharmeuropa. EDQM notes that “finished product monographs will be elaborated according to the same general principles as for other monographs in the Ph. Eur. to ensure the same high […]

EDQM Publishes List of Texts Adopted at the March 2014 Session of the Ph. Eur. Commission

In mid-May, EDQM released the list of texts that have been adopted by the European Pharmacopeia for implementation in April 2015. The new and revised texts contain monographs as well as general chapters and will be published in Ph. Eur. Supplement 8.4.

USP Begins Call for 2015 Resolutions

In late April, the USP Council of the Convention began its call for resolutions to be deliberated at the 2015 Convention. The proposal period for resolutions is open until February 6, 2015. However, proposals made before October will be considered for the Preliminary Resolutions Report. Information on the review process as well as frequently asked […]

ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe

The effort in Europe to update its expectations for process validation (PV) to reflect the quality management principles underpinning ICH Q8-11 moved closer to completion in late February with the issuance of a final guideline on PV submissions for medicinal products and a draft revision of EU GMP Annex 15....
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