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Regulatory workflow for Registration of Biosimilar products in Egypt. Presented by: Dr /Mona Saleh. Biologicals Registration Directorate Central Administration for Pharmaceutical Affairs www.eda.mohealth.gov.eg biosimilars@eda.mohealth.gov.eg. Topics discussed in the presentation.

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regulatory workflow for registration of biosimilar products in egypt

Regulatory workflow for Registration of Biosimilar products in Egypt

Presented by: Dr/Mona Saleh

BiologicalsRegistration Directorate

Central Administration for Pharmaceutical Affairs

www.eda.mohealth.gov.egbiosimilars@eda.mohealth.gov.eg

topics discussed in the presentation
Topics discussed in the presentation
  • Establishment History
  • Mandate Legal Frame Work
  • Structure of regulatory bodies
  • Biologicals in Egypt
  • Similar Biological products
  • Development of a Biosimilar product
  • Registration of a Biosimilar Product
  • Reference guidelines
establishment history
Establishment History
  • Presidential decree (398/1995)

For NORCB establishment.

  • Presidential Decree (244/2009)

executive aspect for NORCB functions.

  • Administrative decree (16/2009)

Establishment of Biological Products Registration Department

  • Administrative decree (3/2009)

Establishment of Biological Products Inspection Directorate

  • Ministerial Decree (297/2009)

Rules & procedures for Registration of Biological products , vaccines, serums & blood derivatives.

mandate legal frame work
Mandate Legal Frame work
  • Pharmacy Law (127/55)

Specially Article 58 , 59 ,60 ,61.

  • Ministerial Decree (95/2005)

Assignment responsibility of approving clinical protocols to the Ethics committee of clinical research

  • Ministerial Decree (297/2009)

Rules & procedures for Registration of Biological products , vaccines, serums & blood derivatives.

  • Ministerial Decree (26/2009)

For the charges(fees) rendered for CAPA services.

  • Ministerial Decree (399/2010)

Assignment responsibility of approving protocol & following up the process of clinical trials to NORCB

  • Ministerial Decree (632/2010)

Instruction of evaluation working parties of biological

structure of regulatory bodies
Structure of regulatory bodies

Minister of Health

Minister Assistant for Pharmaceutical Affairs

National Organization for Research & Control of Biological “NORCB”

Central Administration for Pharmaceutical Affairs “CAPA”

General

Inspection Directorate

General

Registration Directorate

Biological products

Inspection Directorate

Biological Products

Registration Directorate

biologicals in egypt1
Biologicals in Egypt

Classes of Biological products

Scope of this presentation is

All Biological product Classes other than Blood Products and their recombinant analogues, Vaccines and Sera

  • Blood derived products
  • Vaccines & Sera
  • Epoetins
  • Interferons
  • Heparins
  • Monoclonal Antibodies
  • Cytokines
  • Hormones
  • Insulins
  • Miscellaneous
biosimilars
Biosimilars

Biosmilar product is defined as:

Biological product (other than blood derived products and their recombinant analogues, vaccines and sera) having the same active substance, dosage form, Strength and route of administration of a reference biological product and has proven through a comparability program that its quality, safety and efficacy is equivalent to a reference biological product when prescribed in a claimed indication

reference vs biosimilar
Reference Vs. Biosimilar

Biosimilar

Reference

how to develop a biosimilar product
How to develop a biosimilar product

Step wise Biosimilar development process:

Comparability exercise is part of the development process of the biosimilar product

how to develop a biosimilar product cont
How to develop a biosimilar product (cont.)

Reference selection

  • A single reference product must be used for all comparability exercises during the development process (i.e. quality, safety and efficacy).
  • The reference product should be justified by the manufacturer of the biosimilar product according to the following criteria:
how to develop a biosimilar product cont1
How to develop a biosimilar product (cont.)

Reference selection (cont.)

The Reference product should be either licensed in Egypt

Or

Licensed and widely Marketed in a reference country for at least 4 years

final dossier approach cont
Final dossier approach (cont.)

CAPA

Biological Registeration Directorate

Front Office

Required Docs

Company

Approval

DisApproval

Time Line  15 Working Days

final dossier approach cont1
Final dossier approach (cont.)

CAPA

Pricing Committee

Required Docs

Company

Price

Time Line  60 Working Days

final dossier approach cont2
Final dossier approach (cont.)

CAPA

Biological Registeration Directorate

  • SMFs, M.P & process validation (inspection department)
  • Stability studies (stability committe)
  • M2
  • (Biologicals evaluation committee))
  • PSUR, RMP & DDPS (PVC)
  • M3,M4, M5 (NORCB)

Complete CTD

Company

Time Line  60 Working Days

final dossier approach cont3
Final dossier approach (cont.)

CAPA

Biological Registeration Directorate

  • (EWP decision, PVR, Stability R, TAR, Analysis report, Insert, Pack)
  • Technical Committee Submission
  • Issue Registration license

Time Line  60 Working Days

stepwise approach local products cont1
Stepwise approach (Local Products) (Cont.)

CAPA

Biological Registeration Directorate

Front Office

Required Docs

Company

Approval

DisApproval

Time Line  15 Working Days

stepwise approach local products cont2
Stepwise approach (Local Products) (Cont.)

CAPA

Pricing Committee

Required Docs

Company

Price

Time Line  60 Working Days

stepwise approach local products cont3
Stepwise approach (Local Products) (Cont.)

CAPA

Biological Registeration Directorate

1- ASMF

2- SMF of API

Company

  • Technical Committee Submission

SMF of API

  • CAPA
  • Biological
  • Inspection
  • Directorate

ASMF

NORCB

  • (Finished product manufacturing & Control
  • – perform Stability studies – preclinical studies)

Time Line  60 Working Days

stepwise approach local products cont4

Performing Clinical trials

  • Supervising the process by NORCB
Stepwise approach (Local Products) (Cont.)

DuringThe 3 Years

CMC, Preclinical,

Clinical Protocal

CAPA

Biological Registeration Directorate

Company

  • Clinical protocol evaluation (Ethics committee at M.O.H & NORCB
  • M.P & process validation Evaluation (inspection department) CAPA
  • Stability evaluation (stability committee)
  • Charact. & Anal. procedure evaluation at NORCB (registration analysis certificate)
  • Preclinical studies evaluation (NORCB)

Approval

stepwise approach local products cont5
Stepwise approach (Local Products) (Cont.)
  • RMP & DDPS (PV center)
  • M1 evaluation (Front office department)
  • Clinical studies evaluation (Biologicals evaluation committee)

CAPA

Biological Registeration Directorate

Complete CTD

Company

Time Line  60 Working Days

stepwise approach local products cont6
Stepwise approach (Local Products) (Cont.)

CAPA

Biological Registeration Directorate

  • (EWP decision, PVR, Stability R, TAR, Analysis report, Insert, Pack)
  • Technical Committee Submission
  • Issue Registration license

Time Line  60 Working Days

reference guidelines
Reference guidelines

Global:

WHO- GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs)

ICH guidelines

ICH - Pre-clinical safety Evaluation of Biotechnology-derived pharmaceuticals S6

ICH- General consideration for clinical trials E8

ICH- Statistical principles for clinical trials E9

ICH- Quality of Biotechnological products: Stability testing of Biotechnological/Biological products Q5C

ICH- Derivation and characterization of cell substrates used for production of Biotechnological/Biological products Q5D

ICH- Viral safety evaluation of Biotechnology products derived from cell lines of human and Animal origin Q5A

ICH- Development and manufacture of drug substances (chemical entities and biotechnological/biological entities Q11

reference guidelines1
Reference guidelines

EMA-Overarching biosimilar guidelines

EMA- Product-specific biosimilar guidelines

EMA- Other guidelines relevant for biosimilars

EMA- Scientific Guidelines on Biological Drug substances

EMA- Scientific Guidelines on Biological Dug Products

FDA- Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

FDA- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

CDSCO- Indian Biosimilars Guidelines