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Biosimilar Infliximab Receives Approval in Japan and Turkey

South Korean based Celltrion, received approval for its biosimilar Infliximab in Japan and Turkey in July. The product was developed in collaboration with Hospira, and has been approved in Europe (2013) as well as in South Korea and Columbia.

Caribbean Countries Consider Creating Generic Drug Registry

In mid-July, the Caribbean Public Health Agency (CARPHA) reported that countries of the Caribbean are discussing the establishment of a unified registration process for generic medicines. This process would improve availability, quality, and access to essential medicines within member countries under a framework of developing and strengthening the sub-regional drug regulatory system, CARPHA maintains.

Healthcare Veteran John Bournas to Head ISPE

ISPE named John Bournas as its new president and CEO in late July, succeeding Nancy Berg who has held the position since the beginning of 2012. Bournas is a veteran in the healthcare field, having served in management positions at the American College of Cardiology and Cardinal Health, and most recently as CEO/Executive Director for […]

Pharmacopeial Modernization and Harmonization Efforts Spurred by Global Supply Chain Regulatory Needs; China’s Pharmacopeia Among Asian Participants

The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes....

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, June 2014

In focus are: ● FDA’s new process for risk-ranking ANDAs ● an update on other FDA efforts under GDUFA to clarify and streamline its generic drug review process ● the pressure coming from industry to establish an independent review process for new and modified excipients ● advice from FDA compliance experts on proactive GMP communications, and ● the compelling results of Amgen’s eight-year effort to upgrade its nonconformance investigations and follow-up processes to find and address root causes....

India Offers Bounty for Whistleblowers on Fake Medicines

In a mid-July circular, India’s Central Drugs Standards Control Organisation (CDSCO) announced the offer of rewards for whistleblowers who report on goods that are confirmed as “spurious, adulterated, and/or misbranded.” Rewards have been set at up to 20% of the total value of intercepted shipments of goods. The maximum value of the reward is 2.5m […]

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 […]

Changes in India’s Serialization Expectations

India announced in a late June public notice that it now considers mono cartons containing strips, vials, or bottles of pharmaceutical products as secondary, rather than primary packaging, for the purposes of serialization. The Directorate General of Foreign Trade of India requires secondary packaging to carry a barcode encoding a unique product identification code, batch […]

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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