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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....

APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....

Brazil Guidance on Track-and-Trace Requirements

Brazil’s regulatory authority ANVISA has published a guidance on the reporting requirements for its medicine track-and-trace system (see IPQ “News in Brief” January 31, 2014), which is due to come online in 2016. It specifies that transactions must be reported to the regulator by uploading XML files to its website detailing events such as packaging, […]

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....

FDA Funds PAHO Cooperative Agreement

In early July, FDA’s Office of International Programs (OIP) announced the granting of funds to support a single source cooperative agreement with the Pan American Health Organization (PAHO) to foster cooperation and strengthen regulatory systems in the Americas. This cooperative agreement will support collaboration and investigation in the following areas: ● developing and applying regional/global […]

China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades

China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight....

FDA and PANDRH Begin Work on Regulatory Competencies

In late May, FDA and the Pan American Network for Drug Regulatory Harmonization (PANDRH) began developing a set of regulatory competencies by which to drive regulator training. Another objective of the collaboration will be to analyze data from evaluations of regulatory systems in the region to decide on future activities and benchmark success.

Warning Letters Go To Anti-venom and Allergenic Extract BLA Holders

In mid-April, FDA issued warning letters to Instituto Bioclon’s Mexico City anti-venom facility and Greer Laboratories allergenic extract plant in North Carolina. Both biologics facilities were cited for deficient environmental monitoring and failure to conduct investigations.

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....

Brazil to Require Notice One Year Prior to Drug Withdrawal

A new mandate, approved by Brazil’s Anvisa in late March, requires drug manufacturers to provide a year’s notice prior to removing a drug from the market if that withdrawal could lead to a shortage. If the withdrawal would not pose a risk of a shortage, the notice can be given six months ahead rather than […]
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