GMP Compliance Problems may cause Drug Shortages

GMP compliance and manufacturing problems may lead to supply shortages of medicinal products in Europe. In the US drug shortages due to compliance and/or manufacturing problems have been an issue for quite some time. It is an increasing problem that manufacturers of medicinal products reduce manufacturing capacities to improve cost efficiency. In addition many products are no longer manufactured in-house but at contract manufacturers.

If a manufacturing site is out of compliance the scenario is very different compared to the situation 10 years ago. In the past additional manufacturing sites were able to increase production and to supply products to the different markets. Today a shut down of a big manufacturing site because of GMP deficiencies may result in drug shortages because no other site would be able to take over the additional capacity. The US FDA is even contacting competitors of the manufacturer concerned to assure the supply of medicinal products.

In Europe the topic has been on the agenda of the EMA Management Board work programme 2012. The Management Board initiated the discussion on a ‘Reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems’, which "summarises the lessons learned from previous crises where the Agency had a supporting or co-ordinating role and presents short and mid-term actions that may allow the EU network to prevent, mitigate and manage shortages of important medicines."

The new written (GMP) confirmation for APIs may also cause drug shortages because some companies may not be in the position to obtain a written confirmation from Non-EU Authorities by 2 July 2013. The EMA published the outcome of a workshop on 10 September 2012 as a Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems on 4 October. The European Commission has asked EMA to prepare a methodology for risk analysis for central authorised products and to share this methodology with the Member States. According to the reflection paper 50 centrally authorised products are clearly at risk and additional 150 central authorised products are potentially at risk.