Last week, I attended the PDA/EMA joint conference in Cascais, Portugal. The topic was on compliance, a prerequisite for availability of medicinal products. The conference kicked off with a plenary session on the impact of the new falsified medicines directive (FMD) on regulators and the pharmaceutical industry. Belen Escribano Romero from the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), a public body that belongs to the Spanish Ministry of Health, provided an overview of the main changes in the new legislation, which included, amongst others, the importation of APIs and excipients from third-world countries, inspection planning, revisions of the GMP guidelines, new GDP guidelines for the distribution of medicinal products by wholesalers and brokers, as well as pending regulations relating to safety features and purchasing medicines via the internet. It is hoped that these additional requirements will increase the quality of medicinal products, reinforce supply-chain security and prevent penetration of counterfeits, and better protect those buying medicines online.
John Kerridge from Eli Lilly shared an industry’s perspective on how the FMD will impact pharma. He began by pointing out the harsh reality that customs seizures of counterfeits have been on the rise, illegal trading channels are increasing because of the internet and now, even legal trading channels have been targeted by drug criminals. ‘In this industry, patient trust is paramount,’ Kerridge said. ‘The risks are real. All actors play a role in supply-chain security. We must fully support the intent of the directive. The industry should be and is actively involved in implementing effective countermeasures.’ The FMD has made provisions for the importation of active substances and excipients; registration of manufacturers, importers, and distributors; increased enforcement and oversight; and enhanced inspection programs. Kerridge stressed the industry must work together to ensure that the regulations focus on the risks and are effective.
Aldo Giorgetti from Novartis then discussed the various challenges involved in ensuring the availability and quality of drugs. For example, globalization and the complexity of the supply chain have evidently contributed to increased risks. With so many players involved in an increasingly complex supply chain, Giorgetti emphasized the importance of supply-chain integrity as well as the necessity to ensure that there is no contamination of APIs, raw materials and excipients, and that medicinal products do not degrade during transportation. Best practices such as conducting audits of manufacturers from starting materials were presented.
The second half of the day was filled with parallel tracks on a broad range of topics, from inspection trends, regulatory affairs, quality systems, and trends in manufacturing and quality by design to FMD implementation, regulatory considerations for biologics and biosimilars, and GMP links to pharmacovigilance. I could see that most of the attendees were spoilt for choice; in fact I saw some running frantically from room to room trying to get a taste of the different presentations. There was a networking reception in the evening to finish off the first day, which felt like a long one. However, it was really encouraging to see the amount of effort that regulators and the industry are putting into protecting the public from falsified medicines.