At the end of October, the EMA reached out to industry after being informed about the potential for disruption in manufacturing of aseptically produced medicines due to significant difficulties in obtaining single-use-system components (sterile components). The purpose of the request was to help the Agency gather information to gain a better understanding of the causes for, the prevalence of, and any possible approaches to mitigate the shortages of sterile components. The following is the specific text of the request:
The Agency wants to gain a better understanding what the causes are, how widespread this issue is for manufacturers in the EU, and what mitigation measures industry is putting in place. In particular, we would appreciate if you could further information on the impact on availability of (critical) medicines.
In order to determine what regulatory measures could be appropriate in this situation, it would be necessary to substantiate that:
- they would be able to resolve or at least substantially mitigate the issue (i.e., if it is use of alternative systems, that alternatives are available);
- the risks involved are considered acceptable and outweighed by the benefits of avoiding shortages/not delaying availability and for mitigating risk;
- any deviations from normal requirements would be as minimal as possible.
The Agency requested responses be provided by Nov. 15. Based on the urgency and importance of the information, PDA quickly responded with the development and launch of a short survey. The survey was focused on the availability of single-use-system (SUS) components for companies with sterile product manufacturing operations in the European Union, United Kingdom, or United States. For companies that have operations outside of the European Union, United Kingdom, or United States that wanted to take part in the survey, there was an option to select “Other Countries.”
Over 100 responses were received.
Respondents indicated the use of many types of SUS components (e.g., tank bags, filtration bags, storage bags, mixing bags, tubes, bioreactors, connectors, fittings, manifolds, filling needles, sampling assemblies) in the manufacture of their sterile products. According to the majority of the respondents, shortages are occurring for many of the component types.
The survey also provided information on potential alternatives available (even if not approved) and the risk of using such alternatives.
PDA has made the results and raw data available on the COVID-19 updates page.