1K.B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwa Vidyalya, Gandhinagar, Gujarat.
2 HOD of Pharmacognosy & Regulatory Affairs, K.B Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwa Vidyalya, Gandhinagar, Gujarat.
3Associate Professor of Pharmacognosy Department, K.B Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwa Vidyalya, Gandhinagar, Gujarat.
This article presents a comparative examination of the post-approval changes requirements governing pharmaceutical drug products and drug substances in the United States (USA) and Canada. Regulatory frameworks in both countries are crucial for ensuring the safety, efficacy, and quality of pharmaceuticals while facilitating innovation and access to healthcare. the research methodology involves a thorough examination of relevant guidelines, regulations, and case studies from both countries. Key factors such as the types of changes, submission requirements, approval processes, and timelines will be scrutinized to understand the intricacies of regulatory compliance. Additionally, the impact of these requirements on industry practices, innovation, and patient access to medicines will be explored.
Once the drug's regulatory authority (RA) in a given nation has approved its commercialization, the manufacturer may recognize the need for adjustments to a registered dossier and make such suggestions. The concerned RA must provide their prior approval if the proposed modification is believed to have an impact on the drug's quality, safety, or efficacy. Through the submission of an application known as a "post approval change submission," these modifications are communicated to the relevant authority for review of the suggested changes. For submissions of post-market changes, numerous nations have their own regional laws. Information about post-approval changes is available in the United States of America through the Scale up and post-approval changes" guidance and in Canada known as post NOC guidance as per health Canada authority. (1)(2)
DISCUSSION:
USA:
Post approval filing category in USA
Common annual report format in USA.
Forms require for annual report: 2252
1.1 FDA form (356h)
1.2 cover letter
1.13.1 non clinical
1.13.2 summary of clinical study
1.13.4 labelling
1.13.5 summary of manufacturing changes
1.13.7 summary of significant information
1.13.11 distribution data
1.13.12 post market commitment
1.13.13 status of other post market study
1.13.14 log of out standard business Attachment
3.2.s.2.1 DMF amendment
3.2.s.4.1 API specification
3.2.s.4.2 STP API
3.2.p.3.3 trend data, equipment documents
3.2.p.4.1 product specification
3.2.p.4.2 product standard testing procedure
3.2.p.4.4 impurity document
3.2.p.7 container closure system specification
3.2.p.8.3 stability data
CANADA:
There are 4 categories of post-notice of compliance (NOC) changes
This type of modification has a substantial potential to adversely affect the identity, strength, quality, purity, or potency of a drug product, thereby impacting its safety or effectiveness.
Filing category: supplement
supporting document should be submitted to health Canada for review prior to implementing the change.
This type of modification has a moderate potential to adversely affect the identity, strength, quality, purity, or potency of a drug product, thereby impacting its safety or effectiveness.
Filing category: notifiable changes
supporting document should be submitted to health Canada for review prior to implementing the change.
(not applicable to human pharmaceutics)
A minor change refers to a modification that has minor or less effect to the identity, strength, quality, purity, or potency of the drug product.
Filing category: annual notification
Supporting document should not be submitted, but should be available to health Canada upon request.
supporting document should be kept record by the sponsor or manufacturer. (2)
Annual report format in Canada:
Forms for annual report-3011
The following documents should be including, where applicable, with the sponsor’s annual drug notification. A listing of all level III changes for each new drug that has received a NOC and that have occurred in the preceding 12 months compiled using the level III form or format. A copy of the most recent revised label inner and outer) if a level III labels change has been made (7)
COMPARATIVE POST APPROVAL CHANGES IN USA & CANADA
Drug product changes
Table 1. Components and composition changes (4,5)
Table 2. Manufacturing site changes (1,2)
Table 3. Manufacturing process changes (1,2)
Table 4. Specification changes (1,2)
Table 5. Container closure system changes (1,2)
Drug substances changes
Table 6. Manufacturing site changes (1,2,6)
Table 7. Specifications changes (1,2,6)
Table 8. Container closure system changes for drug substance (1,2,6)
CASE STUDIES
USA
Change proposed: change in the API sources/ alternate API sources
Question: can we file CBE-30?
Answer: No
Yes, if API source change within organizations
Required category: PAS
Required documents:
CANADA
Change proposed: change in the API sources/ alternate API sources
Question: Can we file annual notification?
Answer: Yes
Justification: health Canada require only valid CEP,
If API specific site associated with valid CEP has been previously approved either API manufacturing site listed on your company’s DEL.
Required documents:
Annexes as well as attestations from drug substance manufacture in accordance with the guidance document “use of certificates of suitability as supporting information in drug submission
CONCLUSION
Financial Disclosure statement
The author received no specific funding for this work.
Conflict of Interest
The authors declare that there is no conflict of interest regarding the publication of this article.
REFERENCE
Renish S. Pethani*, Dr. Maitreyi Zaveri, Dr. Niranjan Kanaki, Comparative Post Approval Changes Requirement Of Pharmaceutical Drug Product And Drug Substance In Usa And Canada, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 7, 138-143. https://doi.org/ 10.5281/zenodo.12609178
10.5281/zenodo.12609178
