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CDER Safety Research Interest Group Report

The CDER Safety Research Interest Group (SRIG) released a report on identifying drug safety-related regulatory science needs and priorities for the agency in mid-March. Included among the seven areas named was improving product quality and design. The other six were: ● improving access to post-market data ● improving risk assessment strategies ● evaluating risk communication […]

2015 Planned Guidances

In late February, CDER published a list of new and revised draft guidances it plans to issue in 2015. Some of the topic areas of guidances to be issued are: ● biosimilars ● DSCSA implementation, and ● GDUFA completeness for APIs. Some specific guidances of interest are: ● CGMP data integrity Q&A ● environmental assessment […]

Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan

Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management....

Nigeria’s Regulatory Agency Receives Lab Accreditation

Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) lab received ISO 17025 accreditation in January. This accreditation acknowledges the agency’s ability to implement a quality system designed to improve their ability to consistently produce valid results. Having an accredited lab will allow NAFDAC to better assess drugs and fight counterfeiting.

Australian Guidance on Release for Supply

Australia’s TGA issued a guidance on the batch release certification process for marketed medicines. The guidance consists of two parts: ● the general requirements for all manufacturers and sponsors, and ● examples of how the general requirements described in part one can be met for specific areas of manufacture.

USP Elemental Impurities Timeline

In mid-January, USP announced January 1, 2018 as the date of applicability for its chapters <232> and <2332> on elemental impurities. The new date is in alignment with the implementation date for ICH’s elemental impurities guideline Q3D. [Implementation of ICH Q3D is addressed in IPQ October 23 2014.]

Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication

FDA is working with industry, academia, and other regulators globally on major information management initiatives intended to help industry and regulators communicate about pharmaceutical excipients and fill gaps in existing regulatory database efforts, such as the agency’s Inactive Ingredients Database (IID)....

New and Revised FDA Draft Guidances for Industry on Product-Specific Bioequivalence Recommendations

At the end of December, FDA released additional new (28) and revised (15) draft guidances providing product-specific recommendations on the design of bioequivalence (BE) studies to support ANDA submissions. The guidances were developed in accord with the process described in the agency’s 2010 guidance on “Bioequivalence Recommendations for Specific Products.” Comments on the new drafts […]

Final FDA Guidances on Providing Regulatory Submissions in Electronic Format

FDA issued two final guidances – for general e-submissions and study submissions – on submitting electronic versions of NDAs, ANDAs, BLAs, and INDs. The draft versions were issued in February 2014. Changes to the documents included clarifications on: ● which INDs and BLAs are addressed ● the waiver process ● when the agency will refuse-to-receive, […]

SUPAC Manufacturing Equipment Addendum

A final scale-up and post-approval changes (SUPAC) addendum on manufacturing equipment was issued by FDA in December. It presents filing requirements for broad categories of unit operations when making equipment changes. The addendum supersedes the former equipment addendum in SUPAC-IR/MR, for solid oral dosage forms, and SUPAC-SS, for non-sterile semisolid dosage forms. A draft of […]
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