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WHO Report on Suspect Medical Products

WHO issued a report in late March on a meeting held in October to discuss “substandard/spurious/falsified/counterfeit medical products.” The report includes recommendations for health authorities on strategies for detecting and dealing with suspect and substandard medicines, as well as the prioritized actions member states are taking to prevent their production and distribution.

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....

APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....

IPQ Monthly Update, February 2014

In focus are the nexus of problems facing industry and regulators in the global CMC arena. The stories explore: ● the post-approval change constrictions in Japan and how they compare and interface with those globally ● the discussions among a panel of global regulators on expediting reviews, and the implications for the CMC review process ● the impact that the global regulatory maze is having on vaccine suppliers, and ● the challenges the biotech industry faces in making even minor, low-risk changes post-approval, and what needs to be done to address them....

Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications

Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation....

Regulatory Pathways Are Opening Up Globally for Biosimilars

Implementation of biosimilar legislation in India and Brazil, an increase in drug review staff in Japan, and the publication of a draft monograph for monoclonal antibodies to be included in the Chinese pharmacopeia are among the regulatory efforts taking place across the globe that expand the opportunities for biosimilars....

China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....

China’s SFDA Begins Inspections of Overseas Manufacturers

China’s State Food and Drug Administration (SFDA) is initiating inspections of pharmaceutical manufacturing facilities overseas that sell products in China as part of its ongoing effort to modernize and harmonize regulatory practices with international standards and ensure the quality and safety of medicines sold in its country.

WHO, USP and PDA Make Substantial Contributions to GDP Guidance Canon

The international pharmaceutical community is continuing to expand and refine its guidance for good distribution practices (GDPs) to give industry the tools it needs to protect and assess product quality in the face of the many hazards of a complex global supply chain....

Latin America Diverges Widely on CMC Requirements; Harmonization Effort Continues Through PAHO

While momentum is growing in Latin America for more harmonization around the technical requirements for registering pharmaceuticals, currently there are significant divergences among the countries in the region regarding the expectations for the form and content of CMC submissions....
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