When regulatory worlds collide: A questionnaire-based study to understand gaps in the current global regulation’s paradigm for combination products (drug-device)

Dhiraj Behl, Tanveer Naved, Harikesh Kalonia, Janine Jamieson

Center for Drug and Regulatory Affair, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India

ABSTRACT

The current study addresses the issues and challenges faced by industry and regulators from early planning for CP development to facilitate time to market with patient-centric solutions and commendations. Global CP regulations are evolving, and a literature study noted ambiguous definitions, inconsistent designations, filing requirements, and little uniformity in the application and assessment of registration processes. The online study was conducted from June 2021 to August 2021 to understand industry challenges around different regulatory world of drugs and devices. The questionnaire was prepared via primary and secondary research having 20 imperative questions/comments that were given to participants after explaining the purpose of the study. Since the questionnaire was broad and cannot cover everything in one research paper, it was decided to split the outcomes in into two parts on Combination products (CP’s) i.e. (i) 10 questions - To understand globally basic understanding & gaps (ii) 10 questions – Understand the current situation of technical requirements for registration (Pre to post). The online responses were gathered as agree/disagree, yes/no/maybe, or comments and analyzed by descriptive statistics. This work has demonstrated that in the current understanding of CP’s globally, there is a limitation regarding the qualified personnel involved in CPs development and lifecycle management. of the 194 respondents, approx. 95�lieve that there is a lack of expertise in this field or failed to answer.

Keywords:

Drug delivery device, Drug delivery, Primary mode of action, Combination products