On 13 November 2013, Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) announced the next step of their joint efforts toward regulatory harmonization and the launch of a joint regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
The European Commission has published a report that takes stock of the progress made in personalised medicine, and the opportunities and challenges it presents for healthcare systems.
The European Medicines Agency (EMA) and the US FDA have published a second joint Q&A document which provides guidance on the quality by design concept, a risk based approach to pharmaceutical development and manufacturing. It involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product quality; these concepts are described in the international guidelines ICH Q8, Q9, Q10 and Q11.
The US Food and Drug Administration (FDA) has proposed a new regulation that would require pharmaceutical manufacturers to provide the agency with advance warning of impending drug shortages.
MHRA has developed a new guidance document for Manufacturing Specials (MS) to ensure consistency during routine Good Manufacturing Practice (GMP) inspections and to ensure MS licence holders are aware of the authorities’ expectations in this complicated area.
The TGA has announced the launch of the Medical Device Single Audit Program (MDSAP) from January 2014, together with Brazil's ANVISA, Health Canada, and the US Food and Drug Administration FDA, to develop a global approach to auditing and monitoring the safe manufacturing of medical devices.
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.