A successful major variation approval

Amidst the pandemic, the supply of a critical active pharmaceutical ingredient (API) threatened the availability of a one-of-a-kind product distributed in Spain. A complex biologic drug for the treatment of cardiac issues in hospital patients that required a specific API from a source in China. However, the pandemic led to supply chain issues which affected this API. With reducing stock levels, a lack of alternatives, and difficulty finding another manufacturer, there was growing concern about the potential impact on patients. In response to this urgent situation, our team at ProductLife Group (PLG) assisted in the submission of a Type II variation application to health authorities so that a new API manufacturer could be registered, ensuring the drug supply.

PLG took the lead on the application strategy, liaising directly with the national health authority, but worked closely with the client’s quality department to ensure all necessary documents were prepared appropriately for the submission. PLG also assisted in communications with the new German API supplier, which was identified by the Italian manufacturer of the finished product. Regular meetings with both parties ensured that all parties understood any potential impact on the final product.

To minimize delays, PLG designed a novel strategy to register the new API manufacturer. This involved informing the inspection and control department, as well as the biologic department, of the urgency of the situation. While most cases would warrant only notifying one department, further awareness and a collaborative effort was needed between teams. In addition, PLG requested regular meetings with the health authority and relevant assessors to discuss any queries on the submission.

Due to ProductLife Group’s proactive approach, the health authority responded in 1 month. Significantly faster than a typical submission, where average response times ranging from 6-months to 1 year. Final approval was granted a few days later, shorting the number of rounds required due to the urgency of the request, responding with a much shorter delay than normal.

ProductLife Group aided this application’s timely response by identifying key stakeholders, acknowledging the required criteria by the health authority to minimise delays and ensure successful approval. By thoroughly preparing documents, conducting regular meetings with all parties, working closely with the client, and notifying authorities of the urgency of the situation, a positive outcome was achieved in a timely manner. PLG responded proactively, efficiently, and professionally, which was reflected in an acceleration of validation and the successful approval of a much-needed product during a critical time.