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China to Implement Drug Distribution Reforms

China’s State Council stated in late February that it would implement drug distribution reforms. According to a Reuters report, this effort is designed to reduce substandard and counterfeit drugs through centralization and ensuring legitimate products reach rural areas.

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....

New CFDA Leader

China’s CFDA announced Bi Jingquan as its new leader in early February. Jingquan, a price management expert, replaces Zhang Yong, who has led the CFDA for two years.

Chinese Pharmacopoeia Opens Lab to Build Compendium

A joint lab was opened by The Chinese Pharmacopoeia Commission and Waters in late January. The lab seeks to produce an official compendium covering both western and traditional Chinese medicines.

CFDA Plan to Improve Inspections

A plan to improve its regulatory inspections was announced by China’s CFDA in late January. The plan calls for increased inspection capacity, improved training, and better information sharing and coordination.

India Formalizes Pre-Submission Meetings

In late January, the Central Drugs Standard Control Organization (CDSCO) of India announced plans to formalize its pre-submission meetings. Informal pre-submission meetings have been taking place for a few years, but stakeholders had been requesting a better window for technical deliberations with regulators.

Drug Controller General of India to Strengthen GMP Enforcement

In late January, the Drug Controller General of India (DCGI) said that they would expand their sample testing program to North Eastern states to better assess drug quality. DCGI had begun testing samples from public healthcare and retail pharmacies to check for quality and efficacy last year in a number of other states.

Japan Approves Lily/BI Insulin Biosimilar

Eli Lilly and Boehringer Ingelheim announced that they had received approval for their insulin glargine biosimilar for Japan in mid-January. The product is a biosimilar of Sanofi’s diabetes drug Lantus. The biosimilar received EC approval in September 2014.

ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda

The ICH Q12 effort to create a more improvement-friendly and harmonized regulatory approach to pharmaceutical product lifecycle management is being driven by concern about the availability and reliability of supply as well as product quality and will address the “tough” regulatory issues involved, GSK CMC Regulatory Strategy VP Moheb Nasr stressed in an update on the ICH initiative in December. Nasr has been appointed to serve as Q12 rapporteur....

IPQ Monthly Update, November 2014

In focus are the structure, function and impact of two components of the new Office of Pharmaceutical Quality that will be on the front line of its industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management. Included on the international front are stories on: ● how the Europe-based association APIC is mapping API requirements in emerging countries and working with them to make their processes more effective and user friendly, and ● IPEC’s efforts to narrow the excipient maker/user communication gap on visible particles....
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