![]() EMA continues to state that industry's risk management tends to be reactive rather than proactive. ![]() The trend to focus manufacturing to a few manufacturing sites supplying at a global level also gives rise to risks. The 2011 tsunami in Japan is given as an example of how natural disasters can impact the supply chain of pharmaceuticals. Uncertain political and regulatory systems and the danger of natural disaster may lead to shortages in the supply. antibiotics, is now wholly located outside the EU. The production of some active substances for life-saving medicines, e.g. Extended manufacture and supply chains also present increased dangers. Globalisation is seen as a further source of danger. In other cases of GMP non-compliance no action could be taken in order to avoid supply shortages. This dilemma stands for the cases in which defective but life saving medicinal products had to be left on the market. EMA talks among other things about the regulators' dilemma. #Ema problems how toThe Reflection paper summarises the lessons learned from previous supply shortages and explains how to manage these shortages. The Network's help will be provided in the form of risk management. Now a European Network is intended to help the Member States that may experience difficulties when faced with pan-European problems in the case of still occurring shortages in the supply of medicinal products. The concept paper for revising Chapter 8 of the GMP Guide points out that requirements concerning the reporting procedures relating to restrictions of supply should also be addressed in a revision of Chapter 8 - whether or not this supply shortage relates to a quality defect. The EU also has recognised this problem and has made it a central issue in all meetings of the Committees for Humans Medicinal Products (CHMP). EU legislation requires marketing authorisation holders and manufacturers of medicinal products to notify the authorities if there is the risk of supply shortages.Īs a result of a high number of shortages of medicinal products, FDA has published a draft Interim Rule at the end of last year regarding revised notification requirements for manufacturers in case of such shortages. ![]() Furthermore, EMA presents short and mid-term actions in the reflection paper to address this sort of shortages. Alarmed by recent medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems EMA has published a Reflection paper that summarises the lessons learned from previous supply shortages and explains the way to address them. ![]()
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