In the past nine months, the US regulator has expanded its inspection team in India from 12 to 19, and opened two more offices in Hyderabad and Mumbai, in addition to its first office in New Delhi. With 135 FDA-approved manufacturing units in India and rising compliance problems this comes as no surprise.
The European Medicines Agency (EMA) has announced details of its new organisational structure with the intention to better support its health mission and its role as part of the European medicines regulatory system.
On October 2, 2013, the EMA’s Management Board agreed to publish the agendas and minutes of all its scientific committees. This is part of the EMA’s approach to increasing transparency and opening up its operations.
The Japanese Ministry of Health (MHLW) and the PMDA have started entering information on good manufacturing practice (GMP) compliance related to Japanese manufacturers, upon the manufacturer's request, into the EudraGMDP database. This is the first time that information from a non-European regulator has started to be added to EudraGMDP. The initiative is expected to speed up regulatory processes and save time for importers, manufacturers and regulatory authorities.
The FDA is announcing the availability of a draft guidance for industry entitled “ANDA Submissions—Refuse-to-Receive Standards.” This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) The guidance describes what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive an ANDA.
With the beginning of this month, the FDA has published the following two updated lists of GMP guidelines:
After more than a year delay, IPEC India is expected to be created by the end of the year. IPEC-Americas’ vice chair confirmed that the registration process is moving forward. Due to difficulties concerning the naming of the organization the formation could not be realized in 2012.
On 24 September 2013, the European Commission adopted two measures to improve the safety of medical devices. The new rules are:
- A Commission Implementation Regulation clarifying the criteria to be met by notified bodies, which are responsible for inspecting manufacturers of medical devices, and
- A Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector.
The European Commission has published the final version of the revised Chapter 2 on Personnel. Changes have been made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. Furthermore, a section on consultants has been added.
The number of PIC/S members is constantly growing. According to PIC/S, Hong Kong SAR’s Pharmacy and Poison Board has applied for PIC/S membership. Rapporteurs for this accession will be appointed at the next PIC/S Committee Meeting in Ottawa in October.
The Falsified Medicines Directive (FMD) has now been transposed into UK legislation and came into force on August 20, 2013. The FMD (Directive 2011/62/EU) introduces a series of measures to prevent the entry of falsified medicines and substandard raw materials into the legal supply chain, including stricter rules on the controls and inspections of producers of active pharmaceutical ingredients (APIs), intensified record-keeping requirements for wholesale distributors, and a common EU-wide logo to identify legal online pharmacies.
FDA is announcing the start of the Secure Supply Chain Pilot Program (SSCPP) in order to assist the Agency in its effort to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the FDA to focus its resources on imported drugs that fall outside the program and may pose risks.
The World Health Organization - supported by the IPEC Federation Member Groups - is currently in the process of revising and updating the „Good Trade and Distribution Practices for Pharmaceutical Starting Materials“ – WHO GTDP guide - which is open for comments for a restricted audience only until September 2013.
The draft is not to be displayed on any web site and will be presented to the WHO Expert Committee during the 48th meeting in October 2013. Following adoption, the IPEC Federation will update its own guide in line with that of WHO.
WHO: Current Projects
The US Food and Drug Administration's (FDA) has announced an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010. The CDER plans to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. The new initiative was published in the latest edition of the Federal Register.