Cook made the prediction at the European Directorate for the Quality of Medicines (EDQM) 50th anniversary conference in Strasbourg, France last week, where he told delegates the current edition of the European Pharmacopoeia is vital to the drug industry.
“If we consider the development of medicines it is clear that there are many opportunities for the use of the use of the contents of the European Pharmacopoeia” said Cook, who was representing the European Federation of Pharmaceutical Industries and Associations (EFPIA) at the event.
“Opportunities are put in to practice through the use of monographs for excipients, perhaps in development of new formulations or clinical supplies, and through the general chapters and general monographs, which provide the basic expectations for dosage forms.”
“All of this activity provides a foundation of accepted legal quality standards that really facilitates the development, submission and review of new medicines basically by allowing the companies and the assessors to focus what is different or critical in a new product.”
Cook also said that, in addition to playing an important role in the European regulatory framework and creation of standards that help assure the quality of medicine for patients, the European Pharmacopoeia is important to global pharmaceutical companies.
“From an innovator company perspective, where you are perhaps considering launching a product on a global basis, the recognition of the European pharmacopoeia in countries beyond Europe is particularly valuable.”
Innovator pharmaceutical companies also welcome the EDQM’s leadership in the area of global harmonisation according to Cook, who added that the organisation’s engagement with new scientific and regulatory developments is also valuable citing various ICH initiatives and QbD as examples.
21st century flexibility
Looking forward, Cook predicted the use of the European Pharmacopoeia will shift, particularly for innovative drugmakers and developers of complex biologics for whom defining the materials used in a particular product is becoming more of a challenge.
“Where is the best value for the content of the compendium? If you consider the complexity of the materials [in new drugs] from excipients through small molecules, biologics and vaccines it is clear that there is a continuum of increasing material and product complexity.
“Individual monographs are perhaps best suited for the simpler materials, but as you move up this continuum of complexity perhaps general monographs are more appropriate because they provide the flexibility that is needed.”
But, despite the prediction about general chapters, Cook said the European Pharmacopoeia should be maintained as a trusted resource through quality monographs, clear revision and elaboration processes involving stakeholders and the appropriate adoption of new technologies.
“I’d like to encourage EDQM to continue their leadership in the global harmonisation and convergence of quality standards” Cook continued, adding that “patients do not benefit from complexity and costs associated with different standards and requirements around the world.”