Early Access Programmes: Regulation Handbook - 2nd Edition

Pharma IQ

Navigating the nuances and complexities of early access programmes has proven to be a resource draining task for pharma firms. The dense regulatory requirements of course exist to ensure that medicines are fit for purpose and efficacious enough to bring value to patients. However, the challenge of merely grasping the web of compliance considerations for varying countries can hinder the path and lead time of these programmes. For example in some regions it is illegal to promote the access to unapproved therapeutic goods, like Australia. Shekar Natarajan, Director and Group Lead - International Regulatory Strategy, of Shire Pharmaceuticals plc noted that referring to the region’s agency website is a logical first step, however reaching out to affiliates local to the area for further insight may also be required as the information provided on requirements may not be accessible online or may not be expressed in a language that can be deciphered by the firm.

Ahead of this year’s Early Access Programmes Europe conference, Pharma IQ expands its regulatory handbook to develop the industry’s awareness of the various compliance requirements that surround the implementation of these programmes.