When import regulations covering APIs shipped to Europe came into effect in July, many feared there would be shortages of vital APIs because regulators in key supply hubs, notably China and India, would be slow to issue the “written confirmations” of quality that must accompany each batch.
But, four months on, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has reported no major issues and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has not had recourse to use its contingency plan.
Which begs the question - were concerns exaggerated? Or is it simply (still) too early to assess the long-term viability of the directive?
European Fine Chemicals Group (EFCG) advisor, Tony Scott, is of the latter view. He told in-Pharmatechnologist.com that API stockpiling as a major factor in the supposed success. “EFCG members reported an increase in business in anticipation of 2nd July laws”, he explained.
Similarly, Julie Chauvet from the European Generic Medicines Association (EGA) told in-Pharmatechnologist.com that “the threat of shortages has so far been mitigated thanks to the early development of comprehensive API supply management strategies and contingency plans by pharmaceutical manufacturers, as well as to the issuance over the last 3/4 months of numerous written confirmations (WCs) by key API exporting countries”.
However, “although no immediate issue has arisen as yet, the generic medicines industry remains vigilant as to the possible occurrence of shortages in the coming months: e.g. API stocks are being depleted, key API exporting countries have not all completed the issuance of the required WCs, some WCs will see their validity expire in the coming year”, continued Chauvet.
Progress in India and China
While stockpiling may be a factor it would be unfair to say no long-term provisions had been made by regulators in supply countries. India and China, which are not listed by the European Commission as ‘equivalent countries’ but are estimated to provide 80% of the APIs entering Europe, have done a significant amount of work
“Chinese authorities are actively supporting the implementation of the regulations. Up to end of August, 322 written confirmations were issued covering 167 Chinese API manufacturers and a total of 524 APIs”, explained Blue Inspection spokesman Stefan Kettelhoit, citing statistics from the 18th October meeting between the European Commission (EC) and EU pharmaceutical and chemical industry associations.
On their side, Indian authorities have planned a total review of their inspections systems.
However, while Kettelhoit believes the “new regulations will overall work over time”, he suggests current reports should be read with caution.
“Based upon the estimated number of Chinese API manufacturers, the number of 167 is quite low”, he continued. Equally, “we may face - after the safety stock has been consumed - certain cases of difficulties for some APIs”, and as there is no clear measure for judging the importance of each API, the real picture is difficult to predict.
The MHRA and the EGA said they will continue to monitor the situation closely for any long-term implications.
Equally, the EFCG, which voiced heavy criticism of the EC for not imposing mandatory inspection, will “keep up the pressure to remind them that it must now be much more feasible than they thought when they completed their Impact Assessment all those years ago”, concluded Scott.