Editor-in-Chief's Commentary: Therapeutic Innovation & Regulatory Science | January 2013
J. Rick Turner, PhD
On behalf of everyone at DIA and also at SAGE Publications, it is a pleasure to welcome you to the inaugural issue of Therapeutic Innovation & Regulatory Science. (You will note that, since it remains the official journal of DIA, the volume number follows sequentially from that of last year’s Drug Information Journal.)
In keeping with our goals of representing all geographic regions in which DIA is active, this issue of the journal contains 3 commentaries with ties to activities in Asia. Dr. Alberto Grignolo has provided a commentary entitled “Collaboration and Convergence: Bringing New Medicines to Global Markets in the 21st Century.”1 It is based on a Keynote Address he gave in May 2012 at the 4th DIA China Annual Meeting, held in Shanghai. Taking a global perspective, Dr. Grignolo discusses ‘‘intelligent innovation” in the biopharmaceutical industry, an approach that is now needed to address higher hurdles in regulatory and pricing/reimbursement landscapes. Among other topics, he also discusses “the emergence of regulatory convergence” and summarizes convergence initiatives that span the globe.
In her commentary entitled “Regulatory Reforms in India,”2 Ms. Deepti Sanghavi discusses how, as a result of adverse publicity concerning the conduct of clinical trials in the country, the Central Drugs Standard Control Organization has taken various steps to streamline regulations and ensure the accountability of stakeholders in biopharmaceutical clinical research. One aspect of the commentary addresses “quantum of compensation” in cases where clinical trial participants experience adverse events and serious adverse events. Another addresses the registration of clinical trials (applicable for surgical procedures, medical devices, behavioral treatment, and other interventions as well as for biopharmaceutical treatment), contract research organizations, and ethics committees.
Five colleagues from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have provided a commentary entitled “The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency, Japan.”3 Following a 2011 paper communicating PMDA’s view on regulatory science,4 this commentary presents an update on the agency’s regulatory science research activity and its roles in the drug regulatory framework. It discusses, for example, the importance of benefit-risk assessment throughout a drug’s lifecycle. As the Institute of Medicine noted, “The [marketing] approval decision does not represent a singular moment of clarity about the risks and benefits associated with a drug—preapproval clinical trials do not obviate continuing formal evaluations after approval.”5 The PMDA has long-established re-examination and re-evaluation systems that contribute importantly to continuously ensuring that a marketed drug has a favorable benefit-risk balance.
My thanks to all authors for providing these instructive commentaries, and I am sure all readers will find them very interesting. Contributions from additional global regions will appear in future issues of the journal.
This is my last Editor-in-Chief’s commentary. It has been a privilege and pleasure to serve the journal, DIA, authors, and readers in this capacity. Until the incoming Editor-in-Chief takes the reins, former DIA President Dr. Richard Day is serving as Interim Editor-in-Chief; the journal will therefore be in good hands in this part of the transition period. I will remain actively involved in various DIA pursuits, and I wish Therapeutic Innovation & Regulatory Science tremendous success.
1. Grignolo A. Collaboration and convergence: Bringing new medicines to global markets in the 21st century. Therapeutic Innovation & Regulatory Science. 2012;47(1):8–15. Search Google Scholar
2. Sanghavi D. Regulatory reforms in India. Therapeutic Innovation & Regulatory Science. 2012;47(1):16–18. Search Google Scholar
3. Asahina Y, Tanaka A, Uyama Y, Kuramochi K, Maruyama H. The roles of regulatory science research in drug development at the Pharmaceuticals and Medical Devices Agency, Japan. Therapeutic Innovation & Regulatory Science. 2012;47(1):19–22. Search Google Scholar
4. Tominaga T, Asahina Y, Uyama Y, Kondo T. Regulatory science as a bridge between science and society. Clinical Pharmacology & Therapeutics. 2011;90(1):29–31. CrossRef
5. Institute of Medicine of the National Academies. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press; 2007.