Knowledge sharing platform: Regulatory affairs_Part 002

15. What is a Marketing Authorization Application?
It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRA-Applications for new active substances are described as 'full applications'. Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’.

16. What is an ASMF?

Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance. In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.

17. What are the types of active substances for which ASMFs are submitted?

New active substances: Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State.

18. What is the difference between DMF and ASMF (with respect to submission)?

ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part). There isn’t any differentiation of DMF’s into parts

19. What is ICH? 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a 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 pharmaceutical product registration.

20. What is CTD?
The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States. Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.

21. What are the modules in CTD?
The Common Technical Document is divided into five modules:
Module 1. Administrative information and prescribing information
Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)
Module 3. Quality 
Module 4. Nonclinical Study Reports (toxicology studies)
Module 5. Clinical Study Reports (clinical studies)

22. What is Orange Book?
It is the commonly used name for the book “Approved Drug Products Equivalence Evaluations”, which is published by USFDA. It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.

23. What is Hatch-Waxman act?

It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts. In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics ”

24. What are the patent certifications under Hatch-Waxman act?

As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following:(I) that the required patent information relating to such patent has not been filed (Para I certification);(II) that such patent has expired (Para II certification);(III) that the patent will expire on a particular date (Para III certification); or(IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.

25. What is meant by 180 day exclusivity?

The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor (Atorvastatin calcium).

26. What are the procedures for Approval of Drug in EU?
·         Centralised Procedure (CP)
·         Decentralised Procedure (DCP)
·         Mutual Recognition Procedure (MRP)
·         National Procedure (NP)

27. What is the Full form of abbreviation, CEP?
Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs.

It is also informally referred to as Certificate of Suitability (COS)

28. What is a CEP?

It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.