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African Medicines Regulatory Harmonization Program Announces Centers of Excellence

In mid-June, the African Medicines Regulatory Harmonization Program (AMRH) announced the establishment of new centers for excellence for regulatory training. According to the New Partnership for Africa’s Development (NEPAD), an arm of the African Union (AU), these institutions will play an important role in increasing the regulatory capacity of Africa as a whole. The role […]

WHO Releases Storage/Transport Supplements

WHO has released for review a set of supplements on its Technical Report Series, No. 961, 2011 Annex 9, which provides a “model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products.” The supplements cover: ● temperature and humidity monitoring systems for transport operations ● temperature and humidity monitoring systems for fixed […]

FDA Issues Draft Guidance on Identifying Suspect Drugs

In early June, FDA announced the release of a draft guidance for industry on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” This is the first guidance issued under Title II of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). It advises drug supply chain stakeholders on how […]

EMA Releases New Guidance and Template for QP Declaration on GMP Compliance of API Manufacturers

In late May, EMA issued a guidance and a template for Qualified Person (QP) declaration of the GMP compliance of API manufacturers. The template is designed to standardize the format of the declaration and reduce the number of follow up questions. The agency recommends its use to “facilitate the validation of regulatory submissions and their […]

FDA Launches “openFDA”

In early June, FDA launched openFDA, an initiative to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. Currently information from the FDA Adverse Event Reporting System is available, but the initiative will soon include datasets on drug labeling and recalls. [For more […]

Progress of FDA’s Compliance/Enforcement Data Transparency Initiative Will Be Spurred by Refined Road Map from Working Groups

The impact of FDA’s compliance/enforcement data “transparency initiative” will continue to increase with the help of a road map released by the initiative’s working groups in late April....

UK MHRA’s Compliance Management Upgrade Includes “Risk Intelligence IT System” for Drug Inspection Targeting

U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is creating a comprehensive “Risk Intelligence IT System” for determining where to deploy its inspection resources that captures and analyzes a wide variety of inputs from industry, public, and agency information sources....

India Looks to Double Drug Inspectors

In mid-May, the Indian government announced plans to double the number of drug inspectors and install quality testing facilities at ports within the next three years as part of a $500 mil. plan to increase India’s drug regulatory capacity. The increase in its oversight program follows in the wake of recent compliance actions taken by […]

New US-EU Mutual Reliance Collaboration

As announced by Deputy Commissioner Howard Sklamberg in the FDAVoice blog in mid-May, FDA has plans to begin a “mutual reliance initiative” with the EU. The stated goal of the initiative is to increase the exchange “of information that is critical to making decisions that protect the public health.” In cooperation with EC and EMA, […]

Dep. Com. Sklamberg on Specialization Needs Within ORA

In an early May blog post on FDAVoice, Deputy Commissioner Howard Sklamberg emphasized that the shifting regulatory environment is creating an increased need for specialization within the agency’s Office of Regulatory Affairs (ORA), and noted the need for experts to contribute to that specialization.
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