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ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....

Infliximab Receives Approval in India

The Drug Controller General of India approved Epirus Biopharmaceutical’s biosimilar Infliximab in mid-September. Biosimilar forms of J&J’s Remicade produced by Celltrion have also recently received approval in both Turkey and Japan (see IPQ “News in Brief” August 7 2014).

China and Taiwan Mutually Recognize Inspections

Chinese and Taiwanese Health Officials have agreed to cooperate on clinical trial regulation and to mutually recognize drug inspections.

Thai FDA to Accept eCTD

In late August, the Thai FDA released draft criteria for the specification and validation of eCTD submissions. The agency is accepting pilot submissions starting in mid-October and plans to accept eCTDs officially by May 2015.

India to Launch Nationwide Study on Substandard Drugs

The Central Drugs Standard Control Organisation (CDSCO) of India is set to begin a study on what areas of the country have a high concentration of substandard drugs. The study is intended to allow CDSCO to have a more focused investigation of the drug supply chain.

Notice on India’s Regulatory Procedures

Following from a meeting discussing Indian regulatory standards, India’s Central Drugs Standard Control Organization (CDSCO) issued a notice in early August to all of India’s state drug controllers on the standards for conducting GMP inspections. Of note is the need for focus on using a risk-based approach for inspections of product development, quality, stability, process […]

India Changes Date for Barcoding Implementation

India, in early August, extended its deadline for the barcoding of pharmaceutical packaging. The labeling being implemented is meant to aid in the track and trace of drug product in order to better secure the supply chain. The requirements for serialization were changed last month (IPQ “News in Brief” July 1, 2014) but the date for […]

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....

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, May 2014

Encompassed in IPQ’s May coverage are in-depth analyses of: ● the evolving excipient regulatory approaches in the U.S. and around the world and the role DMFs are playing ● FDA’s compliance/enforcement data transparency initiative and why it is high on the agency’s agenda ● the UK initiative to refocus its GMP enforcement efforts through more intelligence gathering, and ● finalized guidances from FDA and EMA to help post-approval change management....
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