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REGULATORY AFFAIRS
TOPIC -- POST APPROVAL REGULATORY AFFAIRS
UNDER THE GUIDENCE OF:-
DR. URMILA MAM
PRESENTED BY:-
ABDUL NAIM
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) application to help assure continued safety and
effectiveness (or continued probable benefit, in the case of an HDE) of the
approved drug product of medical device
• A sponsor’s failure to comply with any post approval requirement may be
grounds for withdrawing approval i.e., whether the post approval study will be
terminated or revised/replaced.
• The safety surveillance is designed to detect any rare or long-term adverse effects
over the much larger population and longer time period.
• Harmful effects shown in this trial may result in drug ban or restricted in certain
usages.
• Holders of NDA and ANDA who intended make post approval changes should
follow section 502A of the federal food, Drug and cosmetic act.
• Which provides requirement for making and reporting manufacturing changes to an approval
application and for distribution changes.
• An application must provide specific information to access the effect of the quality, purity, and
potency of a drug product.
Reporting categories:
(1) Prior approval supplement
(2) Changes being effected (CBE) Supplement,
(3) Annual report
CMC (chemistry manufacturing and controls) Post approval Regulatory Submissions : Prior approval
supplement : A prior approval supplement is required for a CMC changes that has a
substantial(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.
It is also referred as Major change
CBE is Referred as Moderate change
Annual report is referred as Minor change
• A prior approval supplement may need to be approved as soon as
possible in the interest of the public health (e.g., drug shortage).
Potential impact on product quality is major. Implementation after
approval of submission.
• Changes being Effected supplement: A CBE supplement is required
for a CMC change that has a moderate potential to adversely affect
the drug product as to its safety or effectiveness. The CANA (changes
to an approved NDA & ANDA) guidance provided for 2 types of CBE
supplements:
(a) Supplement -Change Being Effected in 30 days (CBE -30): Applicant
wait at least 30 days following receipt of the submission by FDA before
distributing product incorporating the change.
(b) Supplement- Changes Being Effected (CBE-0): Implementation
occur immediately upon FDA receipt of submission. Unlike CBE-30
Supplement, a CBE-0 Supplement does not require a waiting period.
Annual Report: The annual report is a periodic, post marketing
submission required by 21-CFR 314.81(code of federal regulation).
Potential impact on product quality is low. Implementation occur
immediately – filled yearly within 60 days of anniversary date of
NDA(new drug application) approval.
Types of CMC Post approval Submission
LABELLING
A. Major
• Based on post marketing study results , labelling changes associated
with new indication and usage.
B. Moderate
Change in the clinical study section reflecting new or modified data
C. Minor
Change in the layout of packaging, FDA regulation editorial changes,
such as adding a distributors name

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Post Approval Regulatory Affairs Changes

  • 1. REGULATORY AFFAIRS TOPIC -- POST APPROVAL REGULATORY AFFAIRS UNDER THE GUIDENCE OF:- DR. URMILA MAM PRESENTED BY:- ABDUL NAIM
  • 2. 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) application to help assure continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved drug product of medical device • A sponsor’s failure to comply with any post approval requirement may be grounds for withdrawing approval i.e., whether the post approval study will be terminated or revised/replaced. • The safety surveillance is designed to detect any rare or long-term adverse effects over the much larger population and longer time period. • Harmful effects shown in this trial may result in drug ban or restricted in certain usages. • Holders of NDA and ANDA who intended make post approval changes should follow section 502A of the federal food, Drug and cosmetic act.
  • 3. • Which provides requirement for making and reporting manufacturing changes to an approval application and for distribution changes. • An application must provide specific information to access the effect of the quality, purity, and potency of a drug product. Reporting categories: (1) Prior approval supplement (2) Changes being effected (CBE) Supplement, (3) Annual report CMC (chemistry manufacturing and controls) Post approval Regulatory Submissions : Prior approval supplement : A prior approval supplement is required for a CMC changes that has a substantial(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. It is also referred as Major change CBE is Referred as Moderate change Annual report is referred as Minor change
  • 4. • A prior approval supplement may need to be approved as soon as possible in the interest of the public health (e.g., drug shortage). Potential impact on product quality is major. Implementation after approval of submission. • Changes being Effected supplement: A CBE supplement is required for a CMC change that has a moderate potential to adversely affect the drug product as to its safety or effectiveness. The CANA (changes to an approved NDA & ANDA) guidance provided for 2 types of CBE supplements: (a) Supplement -Change Being Effected in 30 days (CBE -30): Applicant wait at least 30 days following receipt of the submission by FDA before distributing product incorporating the change.
  • 5. (b) Supplement- Changes Being Effected (CBE-0): Implementation occur immediately upon FDA receipt of submission. Unlike CBE-30 Supplement, a CBE-0 Supplement does not require a waiting period. Annual Report: The annual report is a periodic, post marketing submission required by 21-CFR 314.81(code of federal regulation). Potential impact on product quality is low. Implementation occur immediately – filled yearly within 60 days of anniversary date of NDA(new drug application) approval.
  • 6. Types of CMC Post approval Submission
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12. LABELLING A. Major • Based on post marketing study results , labelling changes associated with new indication and usage. B. Moderate Change in the clinical study section reflecting new or modified data C. Minor Change in the layout of packaging, FDA regulation editorial changes, such as adding a distributors name