Procedure: Generic Drug (ANDA) New MA
Country: Global Procedure
Version #: 01/04/2024
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko
ID: GP-PhR-AND-SR
Category: Pharmaceuticals
Validity: Reg. 5 Years
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
SUMMARY
Generic products undergo rigorous bioequivalence studies to establish their similarity to the reference listed drug (RLD), affirming pharmaceutical and therapeutic equivalence. The generic drug must exhibit identical characteristics in terms of active ingredients, dosage form, strength, and route of administration. The National Regulatory Authority (NRA) meticulously assesses the Marketing Authorization (MA) application, ensuring strict adherence to quality, safety, and efficacy standards. Following the evaluation, the NRA may either grant conditional approval or refuse authorization. Upon a successful review, the NRA issues formal approval, permitting the generic drug to enter the market.
Must-Have Requirements, Recognized Standards, and Certification:
- GMP
- Bioequivalence studies
- Scientific equivalence evidence
- eCTD
- Structured product labeling (SPL)
- Study tagging file (STF)
Nice-to-have:
- ISO 9001
- ISO 17025
- Labeling and packaging compliance
- Intellect. Prop. Rights Evaluation see GP-PhR-IP-SR card
- Regulatory Intelligence and Strategic Consulting see GP-PhR-RI-SR card
- Regulatory Compliance and Gap Analysis see GP-PhR-GAP-SR card
- Authorized Representative see GP-PhR-AR-SR card
Typical Gaps and Deficiencies: Inconsistent regulatory requirements: Different countries may have varying requirements for generic drug registration, leading to a lack of harmonization and potential delays in the approval process. Limited access to reference products: Generic drug manufacturers may face challenges in accessing the reference products needed for conducting bioequivalence studies, which are essential for demonstrating the therapeutic equivalence of the generic drug
Implementation Period: Immediately
Deliverables: Generic Drug New MA
PHASE | TASK | TASK | START | DURATION | Fee | KPI | ||
NUMBER | TITLE | OWNER | W/M/Q/Y | in weeks | 3rd Party | Service | State | |
0 | In-house Pre-Submission Activity | |||||||
0.1 | NDA signing or validation | Executor | week 1 | 1 | ||||
0.2 | Contract Closing | MAH | week 1 | 1 | ||||
0.3 | POA issuance and shipping | MAH | week 1 | 1 | ||||
0.4 | Invoice is sent to MAH and paid | Executor | week 1 | 1 | ||||
0.5 | Legal Document processing | Executor | week 2 | 1 | ||||
0.6 | Legal Document Translations, Notary, and Apostilles | 3rd party | week 2 | 2 | ||||
0.7 | SOW is approved by MAH | Executor | week 4 | 1 | SOW | |||
I | Submission | |||||||
I.1 | Providing documents and registration file | MAH | week 5 | 1 | ||||
I.2 | Ensure alignment with local regulatory guidelines | Executor | week 6 | 2 | ||||
I.3 | Translations and document processing | 3rd party | week 8 | 2 | ||||
I.4 | Filling out the application form | Executor | week 10 | 1 | ||||
I.5 | Approval of the application form | MAH | week 10 | 1 | ||||
I.6 | Submission of the MA Application and Reg. File | Executor | week 11 | 1 | Application | |||
I.7 | NRA payment | MAH | week 11 | 1 | Confirmation | |||
II | NRA Evaluation | |||||||
II.1 | Application review | NRA | week 12 | 2 | ||||
II.2 | Registration file review | NRA | week 13 | 4 | ||||
II.3 | Determining of Specific lab testing requirements | NRA | week 17 | 1 | ||||
II.4 | State-approved lab contracting | Executor | week 18 | 2 | ||||
II.5 | Samples and Ref. Standards permit obtaining | Executor | week 20 | 1 | ||||
II.6 | Samples and Ref. Standards shipping | MAH | week 21 | 2 | ||||
II.7 | Samples and Ref. Standards custom clearance | Executor | week 23 | 1 | ||||
II.8 | Optional clinical evaluation (in some countries) | Executor | week 24 | 8 | ||||
II.9 | Verification of medication guidelines and drug labeling | NRA | week 32 | 2 | ||||
II.10 | Verification of DHCP Letter and Communication Plan | NRA | week 32 | 2 | ||||
II.11 | Approval or Query | NRA | week 33 | 1 | Approval or Q&A | |||
III | Q&A | |||||||
III.1 | Analysis and addressing Qs to MAH | Executor | Mnth 8 | 1 | ||||
III.2 | Answering with relevant documents | MAH | Mnth 8 | 1 | ||||
III.3 | Official Response Evaluation | NRA | Mnth 8 | 1 | ||||
III.4 | Approval or Query | NRA | Mnth 8 | 1 | Approval or Q&A | |||
IV | Approval | |||||||
IV.1 | Market Authorization Approval | NRA | Mnth 9 | 1 | ||||
IV.2 | Reporting to MAH, compliance check | Executor | Mnth 10 | 1 | Approval | |||
IV.3 | Listing in the state register | Executor | Mnth 10 | 1 | Listing | |||
F | Final Phase In-house Post-Authorization Activity | |||||||
F.1 | Service Acceptance Certificate signing | MAH | Mnth 10 | 1 | ||||
F.2 | Final Invoice | Executor | Mnth 10 | 1 | ||||
F.3 | Final Payment | MAH | Mnth 10 | 1 | ||||
F.4 | Contract Termination | Executor | Mnth 10 | 1 | ||||
F.5 | Archiving and limiting access | Executor | Mnth 10 | 1 | Archiving |
Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com