This document discusses regulatory affairs and CMC (chemistry, manufacturing and controls). It provides definitions of regulatory affairs and explains that regulatory affairs professionals ensure quality and safety and manage scientific data. It also describes the key elements of CMC, including the drug substance and product descriptions and manufacturing processes that are submitted in regulatory applications. Finally, it discusses post-approval regulatory requirements, including reporting categories for post-approval changes to applications like prior approval supplements, changes being affected supplements, and annual reports.

1. CMC
[ chemistry, manufacturing &
controls]
PREPARED BY: ASMITA GUPTA GUIDANCE-MRS. ASHWINI MA’AM
M.PHARM:- 1ST YEAR DEPARTMENT OF PHARMACEUTICS

2. REGULATORY AFFAIRS
 Regulatory affairs is a comparatively new profession which
developed from the desire of governments to protect public health
by controlling the safety and efficacy of products in areas including
pharmaceuticals, veterinary medicines, medical devices, pesticides,
agrochemicals, cosmetics and complementary medicines.

3. Critical Elements of Regulatory Affairs
 Regulatory Affairs ensure the Quality and Saftey
 Regulatory Affairs manage the Scientific Data
 Regulatory Affairs Professionals Responsibility
 Regulatory Affairs is a legal adviser

4. WHY REGULATORY REQUIREMENT
APPROVAL?
Many children in the 1960's, like the kindergartner pictured above, were
born with phocomelia as a side effect of the drug thalidomide, resulting in
the shortening or absence of limbs.

5. CTD
(Common technical document)
 INTRODUCTION:-
 CTD was agreed in November 2000 in San Diego, USA.
It provides a harmonized structure and format for new product applications.
 CTD is a set of specification for application dossier for the
registration of medicines and designed to be used across Europe, Japan & US
 CTD was developed by the European medicines agency(EMEA),

6.  CTD is maintained by the ICH (International Conference on
Harmonization) of technical requirement for registration of
pharmaceuticals for human use.
 TheFDA characterized the CTD as “An information package of
 clinical ,non-clinical, manufacturing, technical data in the same format
and with the same content, that would be submitted for
registering new drugs in all three ICH regions i.e.; US, European
Union and Japan.

7. CTD TRIANGLE

8. CTD MODULES
 Module 1 – Administrative Information (Region Specific)
 Module 2 – CTD Summaries (QOS)
 Module 3 – Quality (CMC)
 Module 4 – Non-Clinical Study Reports
 Module 5 – Clinical Study Reports

9. Module 3 Quality (CMC)
1. TOC of Module 3
2. Body of Data-
S - Drug substance
P - Drug product
 A -Appendices
R - Regional Information
3. Literature references

10.  To assure that the drug is safe and effective.
 To assure that the quality of the drug meets appropriate
standards and is consistent.
 To assure that the drug you are
using is the drug described on the label.

11. CMC helps maintain the connection in quality between the
drug used in clinical studies and the marketed drug

12. CMC (RA)
 CMC Regulatory Affairs is a specific area with RA that has ultimate responsibility
for providing CMC regulatory leadership and strategy required to achieve
regulatory approvals.
• CMC RA provides knowledge, understanding, interpretation and utilization of
regulatory guidance and regulations, as well as industry and government agency best
practice and trends.
• CMC RA is a high value-added function within a company that is critical to
successful development, registration, approval and life

13. EXAMPLES
Names and location of manufacturing and testing sites .
Characterization of the API and composition of the dosage form .
Raw materials used to manufacture the API and finished dosage form
Description of the product and process development.
Description of the manufacturing process.
Analytical methods and specifications used for testing and release
 of raw materials, in-process controls, container and closure system,

14. CMC POST APPROVAL REGULATORY
OVERVIEW
 CMC regulatory affairs is concerned with the technical
characteristics of a drug molecule and the dosage form
used for its administration. Typical list of CMC
information required for evaluation.CMC Database or a
New Drug Application :
 Drug Substance
 Drug Product

15.  In the post approval phase, the regulatory affairs
professional is responsible for managing changes to these
conditions.

16. Post approval Regulatory Affairs
 The FDA may require a post-approval study at the time of approval
of a Premarket Approval (PMA), Humanitarian Device Exemption
(HDE), or product development protocol (PDP) for application.
 A sponsor’s failure to comply with any post-approval requirement
may be grounds for withdrawing approval.

17. REPORTING CATEGORIES FOR
POST APPROVAL CHANGES
(1) Prior approval suppliment
(2) Changes being affected (CBE) Supplement, and
(3) Annual report

18. ● CMC Postapproval Regulatory Submissions :
Prior approval suppliment : A prior approval
suppliment is required for a CMC changes that has a
substaintial(major) potential to have an adverse effect on the
identity, strength, quality, purity, or potency of the product as
they may relate to its safety and effectiveness.
(a) Supplement -Change Being Effected in 30 days (CBE -
30)
(b) Supplement- Changes Being Effected (CBE-0) :
Implementation

19. (c) Annual Report : The annual report is a periodic, post
marketing submission required by 21CFR 314.81 . Potential
impact on product quality is low. Implementation occur
immediately –filled yearly within 60days of anniversary
date of NDA approval.