Q. Is it mandatory to conduct BA/BE studies only in healthy human volunteers? Why don't we carry the same research in patients?
● Arulsingh Jayaraman
Besides, the standard SAE definitions (death, life-threatening etc), there are other medical situations which have be assessed for expedited reporting.
ICH E2A guidelines cover these situations:
Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also usually be considered serious.
When a pregnancy occurs in setting of a clinical trial, one has to consider whether it will jeopardize the patient or whether an intervention e.g. abortion is required to prevent the other outcomes e.g. congenital anomaly/birth defect. At the time the pregnancy is detected, it is difficult to predict the outcome and also to be certain that the patient's health is not jeopardized or a birth defect will not occur. Hence, the pregnancy is considered an SAE for expedited reporting.
Q. Can you please clarify in what circumstances does a BA/BE study not require a formal DCGI approval with the current Sch Y and Indian-GCP requirements?
● Dr. Gopal Pai
I feel that a BA/BE study does require DCGI permission as
1) "Clinical trial" means a systematic study of new drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug.
2) BE guidelines released in March 2005 are to be read along with Schedule Y.
3) Definition of new drug includes a drug already approved by the licensing authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new dosage forms (including sustained release dosage form) and route of administration
If we apply the above definitions / guidance to BE, All generic formulations would become new drugs. Hence, they should obtain DCGI approval.
The only exception I can think of is a comparison of a generic marketed in India for > 4 years with a locally marketed innovator brand.
Q. Can you help me to understand the difference between ICH guidelines & Common Technical Document (CTD)? & Why CTD is created?
● Abhishek Gune, Pune
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
The objective of such harmonization is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
The CTD guideline presents the agreed upon common format for the preparation of a well-structured CTD for applications that will be submitted to regulatory authorities. A common format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will ease the preparation of electronic submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. In addition, exchange of regulatory information between Regulatory Authorities wills besimplified.