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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....

Japan and Korea Invited to Join PIC/S

The PIC/S Committee, following a meeting in Rome in mid-May, invited the health agencies of Japan (PMDA) and Korea (MFDS) to join PIC/S at the beginning of July as the 45th and 46th members. Both Japan and Korea had applied for membership in 2012. Applications from the health agencies of Brazil, Hong Kong, Iran, the […]

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....

Burden of Pre-Inspection Submission Requests from Agencies Outside the US and Europe is Growing

Pharma industry experts are expressing concern with a new trend of emerging country agencies requesting significant amounts of manufacturing and facility information prior to performing GMP inspections and are proposing that the international community work toward a more clearly-defined, manageable and harmonized approach....

PIC/S Provides Guidance to Inspectors on Assessing Quality Risk Management

The inter-agency Pharmaceutical Inspection Cooperation Scheme (PIC/S) has released an “Aide-Memoire” intended to assist GMP inspectors in assessing industry’s implementation of quality risk management (QRM) and to help promote a harmonized approach among PIC/S member states....

PIC/S’ Voluntary, Non-Political Status Touted by Regulators Involved

Regulators involved directly in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) continue to view its voluntary, non-political status as a key component of its effectiveness and do not anticipate a move to change that status....

GDPs, APIs, and non-European GMPs on PIC/S Radar Screen as Membership Expands

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) is taking a close look at the developing global guidance on good distribution practice (GDP), including the new guidance that has been emerging from Europe and WHO, in assessing its expansion into the GDP arena. Also on PIC/S’ radar screen are active pharmaceutical ingredients (APIs) and the organization’s relationship to the GMPs of its expanding membership – in particular, those of FDA....

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....

PIC/S Site Master File Guide Updated on Quality Management System Expectations

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has adopted a rewrite of its site master file (SMF) guide for industry that upgrades the expectations on quality management systems (QMS) – and the quality risk management (QRM) and supply chain components in particular – to keep pace with ICH Q9 and Q10....
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