The globalisation of the marketplace for pharmaceuticals means that it is becoming more and more common for medicines destined for consumption in the European Union to be manufactured in distant lands. This creates an additional burden on regulators, who are ultimately responsible for ensuring that these medicines are safe for use by the public.
Recognising this issue, the European Medicines Evaluation Agency (EMEA) is drawing up a guidance document to determine how manufacture, holding times and shipping outside the EU can affect the quality of drugs imported from climatic zones III and IV, i.e. countries outside zones I and II (which include the USA, Europe, Japan, Australia and certain countries in Asia, Africa and the Americas) that can be subject to extreme weather conditions.
Current guidelines on stability testing do not take into account products that are made in the far reaches of the globe, and guidance needs to be developed on the amount of stability dated to be generated, in particular to define the storage conditions to be used, said the agency. It also wants its document to extend to active ingredients and intermediates, as well as bulk and finished products.
The primary concern is that variations in conditions such as temperature, humidity and light may have a significant impact on the shelf life of a medicine to the extent that it may lose therapeutic activity ahead of its marked expiry date.
The EMEA's action comes about as a result of earlier work conducted by the International Conference on Harmonisation, which strives to develop a set of standardised regulations for the development, testing and manufacture of pharmaceuticals.
The ICH updated its own guidance on the stability testing for drugs manufactured in zones III and IV in February of this year, when the drafting process reached Step 4, i.e. when agreement is reached on a text. This triggers a consultation period, organised for the EU by the EMEA's Committee for Proprietary Medicinal Products (CPMP). The comment period for the present document is six months.
Plastic packaging
Meanwhile, the EMEA has started another consultation exercise in order to update its 1994 guidelines on the use of plastic primary packaging materials in light of the Common Technical Document. For the first time, the CTD creates a requirement in the EU for information on the container/closure system for a new medicinal product.
A guidance note will be issued by the EMEA in December and will be subject to the usual six-month comment period.
The CTD, which came into force on 1 July, is designed to make mutual recognition of marketing application dossiers for medicines easier between regulatory authorities around the world.