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China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades

China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight....

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....

EMA and TGA to Collaborate on Orphan Drugs

In a statement published in early April, EMA announced its collaboration with TGA on creating better access to orphan drugs. In the statement, EMA noted that “the two regulators have agreed to share the full assessment reports related to marketing authorisations of orphan medicines.” The statement goes on to note that this strengthens pre-exisiting collaborations, […]

Update Provided on Australia/New Zealand Agency

Australia and New Zealand’s regulatory agencies have provided an update on their progress in developing the Australia New Zealand Therapeutic Product Agency (ANZTPA). The combined agency will cover pre-market evaluation and assessment, product licensing, controls on manufacture, post-market monitoring and surveillance, and setting standards.

Australia to Adopt EMA Biosimilar MAb Guideline

Australia’s Therapeutic Goods Administration (TGA) announced in mid-February that it is carrying out public consultations on its adoption of the EMA 2012 guideline for biosimilar Mabs.

APEC Supply Chain Regulatory Harmonization Effort Gaining Traction

The Asia Pacific Economic Cooperation (APEC) organization is developing and implementing a five-year plan cutting across GMPs, GDPs, pharmacy practices and Internet sales that could have a powerful influence on global regulatory harmonization in the pharmaceutical supply chain arena....

TGA Releases Revised OTC Guidelines for Public Comment

Australia’s Therapeutic Goods Administration (TGA) has released guidelines for comment that revise its framework for the application and approval processes for over-the-counter (OTC) drugs.  Comments are due by February 11. The “Australian Regulatory Guidelines for Over-the-Counter Medicines” (ARGOM) is a set of documents that seeks to: ● provide information to help sponsors of OTC medicines […]

Australia’s TGA Proposes Adoption of Several EU/ICH Guidelines

Australia’s Therapeutic Goods Administration (TGA) is requesting comment on its proposed adoption of several EU and ICH guidelines, and “non-adoption” of one.  The comment period closes on November 9. The following guidelines are proposed for adoption: ● ICH Topic Q3C (R4) Impurities: Guideline for Residual Solvents ● ICH Guideline Q4B Annex 12 to Note for […]

Australia’s TGA Publishes Updated Draft Guidance on Clearance of Products Manufactured Overseas

TGA has released for comment a draft guideline that clarifies its requirements for GMP compliance by overseas manufacturers and further harmonizes those requirements with other international regulatory bodies....
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