Egyptian Drug Authority (EDA)

API Listing & Using of Listed API Quality Instruction

Code: QI:CAPP.061.02

Prepared By:
Name: Position: Signature:

Dr. Doha Ismaeel Senior Assessor/Q. Modu. Eval-U

Technical Review:

Name: Position: Signature:

Dr. Sherief Ibrahim Manager of Spec.Eval-U

Dr. Mohamed Badawi Manager of HUM-TECH-A

Quality Review:

Name: Position: Signature:

Dr. Safaa abu Alaill QA unit manager /CAPP

Approval:

Name: Position: Signature:

Dr. Dalia Abouhussein QA General Manager

Copy No.

Issue / Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: ../../…. Page 1 of 7
Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: ../../…. Page 2 of 7

Document History Table

Date Issue/Rev No. Summary of change Prepared by Reviewed by

-Dr Sherief Ibrahim

New Issue Dr. Doha Ismaeel
12/08/2024 1/0 -Dr. Mohamed Badawi
-Dr. Safaa abu Alaill
 Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: ../../…. Page 3 of 7

1. Purpose
To describe the procedures of screening and evaluation of files submitted according to the API Listing &
Using of Listed API regulating guidelines and regulations.
2. Scope:
All files submitted to the Evaluation unit of specifications in the Administration of Technical Affairs for
human pharmaceuticals for the Optional evaluation of S- Part of Active pharmaceutical ingredients in the
purpose of listing and using of listed Active pharmaceutical ingredients applications by the Active
pharmaceutical ingredient factories inside or outside the Arab Republic of Egypt, their agents or their legal
representatives & Licensed medicinal products' factories or applicant companies recorded in toll
manufacturing register.
3. Responsibilities
3.1 General Manager of General Administration of human pharmaceuticals registration:
3.1.1 Final approval of Optional Technical Evaluation Approval.
3.2 Manager of Technical Affairs Administration:
3.2.1 Approves Optional Technical Evaluation Approval.
3.3 Manager of Evaluation Unit of Specifications for Human Pharmaceuticals:
3.3.1 Follow up the new applications and applicant companies’ responses on the Electronic sheets.
3.3.2 Assign the Screening and/or the Evaluation processes to the assessors.
3.3.3 Approves Optional Technical Evaluation Deficiency Letter.
3.3.4 Approves Optional Technical Evaluation Approval.
3.3.5 Receive and explain inquiries from applicant companies regarding their submitted files at specified
working days.
3.3.6 Follow the timelines, in case non-conformities to timelines an investigation is done determining the root
causes and do a gap analysis consequently a corrective action plans and follow up according to quality
procedure QP:QA.007.
3.4 Senior Assessor:
3.4.1 Performs the screening step of the submitted files after downloading them.
3.4.2 Performs the second technical evaluation of the submitted documents by the applicant company.
3.4.3 Second revision and signing of the Optional Technical Evaluation Deficiency Letter / Optional
Technical Evaluation Approval.

3.5 Specialist Assessor:

3.5.1 Performs the screening step of the submitted files after downloading them.
3.5.2 Performs the first technical evaluation of the submitted documents by the applicant company.
3.5.3 Preparing & signing the Optional Technical Evaluation Deficiency Letter / Optional Technical
Evaluation Approval.

4. Definitions/Abbreviations
4.1 Definitions
4.1.1 Active Pharmaceutical ingredient listing: Listing Active Pharmaceutical Ingredient to be published
in EDA white list of Active Pharmaceutical Ingredients.
4.1.2 Using Listed Active Pharmaceutical ingredient: using Active Pharmaceutical Ingredient which are
listed in EDA white list of Active Pharmaceutical Ingredients
 Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: ../../…. Page 4 of 7

4.1.3 S-Part: The Part of Module-3 of the CTD file that includes requirements for presenting
manufacturing, characterization, drug substance controls, stability characteristics, and other essential
information.
4.1.4 The Common Technical Document (CTD): is a set of specifications for a dossier to be submitted to
the regulatory authorities for the registration/marketing authorization of medicines.
4.1.5 Fast track submission pathway: It is a type of optional submission pathway for locally
manufactured products where the screening & the evaluation of the submitted files are done in shorter
timeframes according to the applicant company’s request after paying extra fees.
4.1.6 Line Extension: It is the addition of another concentration for the same company with the same
pharmaceutical form or in different pharmaceutical forms within the same box of the same active
ingredients for the registered products that have a valid marketing authorization license or for the
under-registration products whose registration procedures are in progress.

4.2 Abbreviations
4.2.1 Spec. Eval-U: Evaluation unit of Specifications
4.2.2 API: Active Pharmaceutical Ingredient.
4.2.3 FPP: Finished Pharmaceutical Product.
4.2.4 CTD: Common Technical Document
4.2.5 WHO: World Health Organization.
4.2.6 ICH: The International Council for Harmonization.
4.2.7 USP: United States Pharmacopeia.
4.2.8 BP: British Pharmacopeia.
4.2.9 JP: Japanese Pharmacopeia.
4.2.10 DMF: Drug Master File
4.2.11 EDA: Egyptian drug authority.
4.2.12 WD: Working day
4.2.13 CAPP: Central administration of pharmaceutical products

5. Forms/Annexes
5.1 Forms
None
5.2 Annexes
5.2.1 Submission of API Listing/Using listed API Electronic forms (Annex I)
5.2.2 API Listing & Using of Listed API “Mail Templates” (Annex II)

6 . Procedures
6.1 Procedure of API Listing:
6.1.1 The Administration of Technical Affairs offers the optional service of “API Listing/Using”
procedure which aims to establish a public database including quality files of the active
pharmaceutical ingredients approved by the Administration of Technical Affairs in the Egyptian
Drug Authority. The applicants for such service will be granted benefits as described in Clause
6.4
6.1.2 The active pharmaceutical ingredient, its data and the version number of this pharmaceutical
ingredient file, which has been approved, shall be listed in the list of active pharmaceutical
ingredients approved by Egyptian Drug Authority. Such listed pharmaceutical ingredient shall
 Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: ../../…. Page 5 of 7

be announced on the Authority’s website to be utilized in registering other medicinal products.

The company owning the active pharmaceutical ingredient shall be obligated vis-a-vis Egyptian
Drug Authority to notify the Authority in the event of any change in the version number or
content of the active pharmaceutical ingredient file. The said company shall be obligated also to
notify the finished product manufacturers of any related change in the active pharmaceutical
ingredient file. Upon technical re-assessment, the database of the active pharmaceutical
ingredient quality files shall be updated and then a new approval for listing shall be issued after
paying the prescribed service fees. The validity of the listing approval shall expire after a lapse
of five Gregorian years from the date of the first issuance. In the event that the listing applicant
is desirous to re-list the active pharmaceutical ingredient, he must submit an application for re-
listing within the last six months of the validity period of the listing approval.
6.1.3 The Manager of Spec.Eval-U receives the applicant company’s application via Submission of API
Listing/Using listed API Electronic forms (Annex I) and assigns the file to the assessors.
6.1.4 The Specialist/ or senior assessor downloads the submitted documents in the shared folders and starts
the screening step of the application as described in “Evaluation of files submitted to the Evaluation
unit of Specifications” QP: CAPP.061”
6.1.4.1 In case that the S-Part of the Quality module from the same supplier with the same version
number was previously assessed & approved by the Administration of Technical Affairs for the
Listing applicant and the applicant company requires to list it; the Specialist assessor prepares
“Optional Technical Evaluation Approval” (QF: CAPP.061.04) as described in “Evaluation of files
submitted to the Evaluation unit of Specifications” QP: CAPP.061” clarifying the granted benefit/s
& the expiry date.
6.1.4.2 In case that the S-Part of the Quality module have not been previously approved by the
Administration of Technical Affairs for the Listing applicant and the applicant company requires to
evaluate it for the first time & list it, the procedure will proceed as described under the “Optional
Technical evaluation Procedure” in “Evaluation of files submitted to the Evaluation unit of
Specifications” QP: CAPP.061” then when approved the Specialist assessor prepares “Optional
Technical Evaluation Approval” (QF: CAPP.061.04) as described in “Evaluation of files submitted
to the Evaluation unit of Specifications” QP: CAPP.061” clarifying the granted benefit/s & the
expiry date.
6.2 Procedure of Using of Listed API:
6.2.1 The Manager of Spec.Eval-U receives the applicant company’s application via Submission of API
Listing/Using listed API Electronic forms (Annex I) and assign the file to the assessors.
6.2.2 The specialist assessor downloads the submitted documents and then revise them with the senior
assessor according to the using of listed API which is published as Notice to Applicant “Guidance on
submission of Active Pharmaceutical Ingredients for Evaluation of Application (Listing of API /
Using Listed API)” (EDREX: NP. CAPP.60) (within 11 WD)
6.2.3 In Case there are required documents from the applicant company; the specialist assessor record
them using "Mail Template No. 1: Using of Listed API requirements" (Annex II) and revise them
with the senior assessor and the unit manager then sends them via email to the applicant company.
(within 4 WD)
6.2.4 In Case there are no more documents required, then the specialist assessor prepares “Optional
Technical Evaluation Approval” (QF: CAPP.061.04) as described in “Evaluation of files submitted to
the Evaluation unit of Specifications” QP: CAPP.061” clarifying the granted benefit/s & the expiry
date. The validity of approval for the use of the listed active pharmaceutical ingredients shall be
connected with the listing approval.
 Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: ../../…. Page 6 of 7

6.3 Manager of Spec.Eval-U shall follow the timelines, incase non-conformities to timelines an investigation is
done determining the root causes and do a gap analysis consequently a corrective action plans and follow up
according to quality procedure QP:QA.007.
6.4 Benefits enjoyed by the holder of the listing application or the user of the listed file:
6.4.1 The holder of the listing application is one of active pharmaceutical ingredients' factories
inside the Arab Republic of Egypt, their agents or their legal representatives: (A1)
In the event that any of the holders of marketing licenses for human medicinal products make use of
listed active pharmaceutical ingredients that were manufactured in one of the active pharmaceutical
ingredients' factories inside the Arab Republic of Egypt (B1), they are entitled to enjoy the
following benefits:
6.4.1.1 Applying for "Line Extension" registration for the same active ingredient without adhering
to the pharmaceutical dosage form specified in the box.
6.4.1.2 Applying for "Fast Track" system to submit the product dossier for registration or re-registration.
6.4.1.3 Additional grace period of 3 months to be added to the original deadline to complete the
registration / re-registration procedures.
6.4.1.4 Modifying the batches release system in case of adding/changing the API supplier, where
submission of Stability Study is the condition for FPP release instead of approving the stability study.
6.4.2 The holder of the listing application is one of active pharmaceutical ingredients' factories
outside the Arab Republic of Egypt, their agents or their legal representatives: (A2)
In the event that any of the holders of marketing licenses for pharmaceutical products, make use of
active pharmaceutical ingredients that were listed by active pharmaceutical ingredients' factories
outside the Arab Republic of Egypt, their agent, or their legal representatives (B2), they are entitled
to enjoy TWO of the following benefits:
6.4.2.1 Applying for the "Fast Track" system to submit the product dossier for registration or re-registration.
6.4.2.2 Additional grace period of 3 months to be added to the original deadline to complete the
registration / re-registration procedures.
6.4.2.3 Modifying the batches release system in case of adding/changing the API supplier, where submission
of Stability Study is the condition for FPP release instead of approving the stability study.
6.4.3 The holder of the listing application is the one who owns the marketing license for the
human medicinal product or his legal representative: (A3)
The holder of marketing license has the right to choose TWO of the following benefits:
6.4.3.1 Applying for "Line Extension" registering for the same active ingredient without adhering
to the pharmaceutical dosage form specified in the box.
6.4.3.2 Appling for "Fast Track" system to submit the product dossier for registration or re-registration.
6.4.3.3 Additional grace period of 3 months to be added to the original deadline to complete the
registration / re-registration procedures.
6.4.3.4 Modifying the batches release system in case of adding/changing the API supplier, where
submission of Stability Study is the condition for FPP release instead of approving the stability study.
6.4.4 The user of listed file which was listed by a third party who is one of the holders of
marketing license: (B3)
In the event that any of the holders of marketing licenses for pharmaceutical products make use of
listed pharmaceutical ingredients that were manufactured in one of the active pharmaceutical
 Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: ../../…. Page 7 of 7

ingredients' factories outside the Arab Republic of Egypt and that were listed by other holders of
marketing license (B3), they are entitled to enjoy ONE of the following benefits:
6.4.4.1 Modifying the batches release system in case of adding/changing the API supplier, where
submission of Stability Study is the condition for FPP release instead of approving the stability study.
6.4.4.2 Appling for "Fast Track" system to submit the product dossier for registration or re-registration.
6.4.4.3 Additional grace period of 3 months to be added to the original deadline to complete the
registration / re-registration procedures.
6.5 All records are maintained according to the control of records quality procedure (QP: QA.010).
6.6 Backing up soft files on share folder maintained according to the Backup of EDA electronic Data
Quality Procedure (QP:QA.041).

7. References
7.1 EDA establishment law and its executive regulation 777/2020.
7.2 Minister decree no. 645/2018 & related complementary guidance.
7.3 EDA chairman decrees.No.213/2023 Concerning Regulating the Rules and Procedures of Listing the
Active Pharmaceutical Ingredients of the Medicinal Products
7.4 Egyptian Guidelines on CTD Quality Module for Human Pharmaceuticals Year 2023- Version 2 – Issue
date 12/03/2023.
7.5 Egyptian Guidelines on Active Pharmaceutical ingredient listing for medicinal products Year 2023-
Version 1 – Issue date 10/4/2023 and its complementary notice to applicants “Guidance on submission
of Active Pharmaceutical Ingredients for Evaluation of Application (Listing of API / Using Listed API)”
(EDREX: NP. CAPP.60) Version 1 – Issue date 16/4/2023
 Egyptian Drug Authority (EDA)

Title: API Listing & Using of Listed API Quality Instruction

Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: --/--/--- Page 1 of 6
Annex І
Submission of API Listing/Using listed API Electronic forms
A. Submission of API Listing/Using of listed API Electronic form
Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date:12/08/2024 Rev Date: --/--/--- Page 2 of 6
Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date:12/08/2024 Rev Date: --/--/--- Page 3 of 6
Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date:12/08/2024 Rev Date: --/--/--- Page 4 of 6

B. Submission of Supplementary documents for API Listing/Using of listed API Electronic form
Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date:12/08/2024 Rev Date: --/--/--- Page 5 of 6
Title: API Listing & Using of Listed API Quality Instruction
Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date:12/08/2024 Rev Date: --/--/--- Page 6 of 6
 Egyptian Drug Authority (EDA)

Title: API Listing & Using of Listed API Quality Instruction

Code: QI:CAPP.061.02
Issue/Rev No.: 1/0 Issue Date: 12/08/2024 Rev Date: --/--/--- Page 1 of 1
Annex ІI
API Listing & Using of Listed API “Mail Templates”

Template 1: Using of Listed API requirements

Dear Dr. /
Concerning the file of the following product, kindly find the requirements to proceed in the Using of listed API
Trade name & Dosage Form: ………………
Generic name and strength: ……………..
Applicant: ……………
Type of application: ▪ ………………….
File Status: ………………………………
Kindly find the following requirements:
1- …….
2- ……..

Kindly note that for any further Questions, Reception is on ….. from …am/ p.m. (Windows no.:…)

We have also developed a survey to gather feedback about your interactions with EDA. Please take a few
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Best Regards,
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