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Ministry of Health license
Lebanon chose to follow the “GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs)” issued by the WHO, as adopted by the 60th meeting of the WHO Expert Committee on Biological Standardization, 19-23 October 2009 to evaluate the submitted SBS Files.
. Guidance For Registration Of Similar Biological Medical Products (Biosimilars) pdf
. List of Requirements for the registration of Biosimilar products according to CTD format pdf
According to these files and in order to register for a similar Biological medical product , a Reference biotherapeutic product(RBP) is used as the comparator for head-to-head comparability studies with the Similar biotherapeutic product(SBP) in the aim of showing similarities in terms of quality, safety and efficacy.
Only an originator product that was licensed on the basis of a full registration dossier can serve as a RBP.
The technical file for Registration of a Locally Manufactured and/or packed under License Generic Chemical Product, shows a list of studies needed including Methods of analysis , stability data, storage conditions, bioequivalence...
.Technical file for registration doc
The Quality module for the drug substance defining the validation parameters needed for a variety of analytical methods of control and describing characteristics to be considered for the validation of analytical procedures are included in a marketing authorization application (MAA).
This document is intended to provide a global policy and guidance for the preparation of the Quality module of Drug Substance for an application file that meet with the requirement of Ministry of Public Health in Lebanon.
.Guide for the quality module3
According to the quality guide module, an analytical procedures used for testing the drug substance should be provided. The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedures:
- Identification tests
- Quantitative tests for impurities' content
- Limit tests for the control of impurities
- Quantitative tests of the active moiety in samples of drug substance
*As MEGBI research Center in AECENAR our goal is to produce local drugs that meets international safety standards according to the recommendations of the Ministry of Health .
---} Starting with Aspirin,
Here we can find the essential analytical Procedures for standard quality tests that we can use to compare our crude aspirin.
.Specifications and Test Procedures (ASPIRIN-USP) .pdf
.Specifications and Test Procedures (ASPIRIN-BP) .pdf
.Specifications and Test Procedures (ASPIRIN-EUP) .pdf
We can find below our comparison table template for a reference Aspirin(RA) and crude Aspirin(CA), according to the European pharmacopoeia.