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International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products....

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, […]

China Issues Regulatory IT Standards

CFDA issued IT standards in late February facilitating interoperability between different parts of the agency. The IT standards focus on food and drug classification and coding, regulatory infrastructure information, a common regulatory support platform, and a software development process specification.

Rx-360 Expanding Presence in China

Rx-360 is introducing a number of initiatives in China. According to Rx-360 Asia Work Group co-leader, Janice Berman, quality assurance VP at Takeda Pharmaceuticals USA, the objective is to set up work groups to help drive activities that have been going on in the US for several years, such as shared resources for supplier audits, […]

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.

The Most-Read IPQ Stories of 2013

As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.] The attention the stories drew is not surprising as they delve into four key current focal points in the CMC/GMP regulatory arena: ● data integrity ● contract relationships ● quality metrics, and ● process validation.

IPQ Monthly Update, October, 2013

The Monthly Update for October includes three stories on FDA's draft guidance on quality agreements with CMOs, more on the FDASIA supply chain implementation efforts, as well as in-depth coverage of ICH’s release of its Step 2 draft of Q3D on elemental impurities. An update on CBER’s compliance initiatives is also provided....

Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment

Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....

IPEC and a Broader Coalition of Industry Associations Identify ICH Q3D Implementation Challenges and What is Needed to Meet Them

The International Pharmaceutical Excipients Council (IPEC) and the Coalition for Rational Implementation of the USP Elemental Impurities Requirements, of which IPEC is a member, have been taking a hard look at where the key challenges lie in implementing the elemental impurity standards in the new Step 2b draft of ICH Q3D and what tools they can provide to assist the pharmaceutical regulatory community in addressing them....

FDASIA Section 707 Draft Guidance on Obstructing Inspections Draws Industry Comments; Investigator Subjectivity Among Issues Raised

FDA’s new draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” has drawn some industry concern regarding the degree of subjectivity it affords investigators in determining when the lines have been crossed....
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