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Drug Evaluation and Registration (DER)

PRESENTED BY: DERD

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ABBREVIATIONS

• API- Active Pharmaceutical Ingredient

• FPP-Finished Pharmaceutical Product

• CMC- Chemistry, manufacturing & controls

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OUTLINE• Legal Mandate

• Drug Evaluation & Registration Department(DERD)

• Drug registration Requirements

• Time lines for registration

• Post approval process

• Re-registration process

• Where to get information

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Legal Mandate

• Part Seven of the Public Health Act, 2012, Act 851- Food and Drugs

– Section 117- Application for registration with prescribed fees

– Section 118- registration of Drugs

• Subsection 6 appeal against registration decision

– Section 119- Cancellation or suspension of registration

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Legal Mandate Cont’d

• Section 147- The Hon. Minister in consultation with the FDA make LI’s prescribing fees for services rendered.

• Section 148- FDA may issue guidelines and code of practice with respect to the registration of Drugs etc.

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Responsibility of DER with respect to Medicine Registration

Oversee the FDA’s regulatory activities with

respect to Medicines Registration to ensure access to quality, safe and efficacious medicines in the health delivery system.

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TYPE OF APPLICATIONS

• New medicinal drug applications

Fresh applications ( New Drugs)

Fresh applications ( Generic)

(Small scale manufacturers applications??)

• Post approval changes (Variation applications)

• Renewal applicationsWORKING FOR YOUR SAFETY 7

List of Products- (under consideration)• Mist Sennaco Eusol Lotion

• Mist Expect Sed Hydrogen Peroxide

• Mist Potassium citrate Calamine Lotion

• Ferric ammonium citrate Gentian Violet

• Methylated Spirit Isopropyl Alcohol (70%)

• Mist Magnesium Trisilicate Mist KaolinWORKING FOR YOUR SAFETY 8

Key registration steps• Letter of intent submitted to FDA

• Products company intends to manufacture

• Composition/ Formula

• Mockup Labels (may be printed on A4 sheets)

• Application submitted

• Documentation, samples, fees

• Application is reviewed

• GMP audit carried out where applicable

• Samples go through quality control analysis

• Product registration Decision communicated to applicant

• Approval/deferred/rejected

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Key registration Requirements

• Quality

• Safety

• Efficacy

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Key Registration Requirements

• Completed FDA Application Form for registration of the listed medicines (form under development)

• Registration Fee (about half of fee for current medicines)

• Samples as per FDA sample schedule

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Key Registration documents• Signed and dated specification of APIs

• Certificate of analysis of APIs

• Batch Formula

• Executed Batch Manufacturing Records

• Signed and dated specification for FPP

• COA of a minimum of two batches of FPP

• Method of analysis of FPP

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Stability Requirement

• Shelf life of FPP is limited to 12 months

• Long term and accelerated stability report will be waived (if shelf life is restricted to 12 months)

• Long term and accelerated stability data will be required for extension of shelf life beyond 12 months

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Requirements for extension of shelf life

Certificate of analysis of the FPP

Long-term stability studies at WHO Zone Ivbconditions for at least three (3) batches

Accelerated stability studies at WHO Zone Ivbconditions for at least three (3) batches

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Use of Monographs and Reference Documents

• Where a monograph/ documented reference exist for analysis of APIs and FPP, it is advised that applicant complies with documented reference

• If analysis of FPPs is not documented in recommended reference books, applicant will be required to submit the method of analysis

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Reference Books

• As per the Public Health Act of 2012, Act 851:

– British Pharmacopoeia

– United States Pharmacopoeia

– European Pharmacopoeia

– International Pharmacopoeia

• Others:

• Martindale

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Application timelines

• Processing of new applications - within 6 months.

• Applicant may be required to provide any requested additional data within 6 months.

• In case additional time is required, a formal request for extension must be submitted

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Contract Analysis• FDA will accept contract analysis performed

on APIs and FPP from third party institutions such as:

– FDA licensed pharmaceutical manufacturers

– Faculties of Sciences of accredited tertiary institutions eg. KNUST, UG, UCC, Technical Universities

– Any such recognized third party laboratory as may be determined by the FDA eg. GSA

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Post Approval changes

• Any change made to the registered product.

Section 148 of the Public Health Act of 2012, ACT 851

✓Administrative eg. change in the name and/or corporate address of the manufacturer of the FPP

✓Change in supplier of API

✓Clinical (eg change in/addition of indication)

✓Change in label information

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Why Post Approval changesThroughout the product lifecycle of a medicinal product, the

applicant/license holder :

– is required to take into account technical and scientific progress and make any amendments.

– May wish to alter / improve the medicinal product or to introduce additional safeguard

– To meet the market requirements-- scale up, adding manufacturing site.

– Others, such as revise SmPC due to adverse drug reactions, new clinical information observed

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SOURCES OF CHANGES

• Applicant/license holder initiated

• Manufacturer initiated

• Regulatory authority initiated, example change in national policy (SP), Pharmacovigilance driven (collected adverse events eg cold and cold, codeine use etc)

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Types of post approval changes

Notification

Minor variation

Major variation

Or

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Post Approval changes-cont

Some changes will require;

New application- eg change of API to a different API, removal or additional of an API to a multicomponent FPP, change to a different dosage form

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Application timelines

• Processing of notification applications –within three (3) months.

• Processing of minor variations- within 4 months.

• Processing of major variations- within 6 months.

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RENEWAL OF REGISTRATIONDue to limited information required for registration:

• Applicant will be required to renew registration annually

• Application for renewal should be submitted one (1) month prior to product registration validity expiring

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Further information

• www.fdaghana.gov.gh

• www.ich.org

• www.who.int

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• Thank you

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