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IPQ Monthly Update, July 2014

IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes....

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....

Revised Draft for eCTD Specifications

In late July, FDA issued a revised draft guidance (and the technical specification documents it incorporates) describing how submissions must be organized and submitted when using eCTD. This revision replaces the 2013 draft and includes changes requiring the use of FDA’s Electronic Submissions Gateway, FDA fillable forms, and specified file formats and software versions.

FDA Will Support Efforts to Upgrade Micro Methods and Processes, CDER Reviewer Affirms

FDA Center for Drug Evaluation and Research (CDER) microbiology reviewers are assuring companies that they will be supportive of efforts to upgrade lab methods and manufacturing processes to take advantage of post-approval scientific advancements....

Top Deficiencies Found in CDER’s Micro Review of Regulatory Submissions Include Incomplete Information on Validation of Aseptic and Terminal Processes

Incomplete media fill information for aseptic processes and an inadequate comparison between production and validation conditions for terminal sterilization are among the microbiology concerns in regulatory submissions that most frequently generate information requests and deficiency letters from FDA’s Center for Drug Evaluation and Research (CDER)....

EMA Recommends 39 Drugs for MA in First Half of 2014

Thirty-nine medicines for human use were recommended for a marketing authorisation (MA) by EMA’s Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014.

Revised EMA Guidance on Advanced Therapy Classification Out for Comment

In late June, EMA released a revised version of its “Reflection paper on classification of advanced therapy medicinal products.” The revision provides further clarification on when medicines may be classified as ATMPs and when they cannot. Clarification is added on: ● what constitutes a substantial manipulation of cells or tissues ● what is considered a non-homologous use […]

IPEC and IQ Consortium Team Up to Push for an Independent Pathway for New Excipient Review

A call to action is reverberating through the pharmaceutical community for the establishment of a viable regulatory pathway for new or modified excipients, which would empower industry to develop more quality-by-design-based formulations....

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.

TGA Update on eCTD Submissions

In late June, TGA provided an update on the progress it has made in being able to accept electronic versions of common technical documents (eCTDs). The agency announced its agreement to purchase software in late February, and has since revised its Common Technical Document Module 1 to further its alignment with the European eCTD. TGA […]
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