The First IGAD Member Countries Regulatory Authorities Conference on Regulatory Collaboration and Possibility of Harmonization

3-5 August 2015, Hilton International HotelAddis Ababa, Ethiopia

Wubshet Mamo, DVM, PhD Clinical Associate Professor of Global Health

Director, Clinical Laboratory System Development & Quality Improvement I-TECH Ethiopia/University of Washington (2007 – 2015), USA

Principal Scientist, Drug Discovery Research AstraZeneca Pharmaceuticals (1993 – 2007), Sweden

National Medicines Quality Control Laboratories (NMQCLs) and Regional Networking Play Crucial Role in the

Identification of SSFFC Medical Products: A model for IGAD Member Countries

DisclaimerThis presentation is based on the presenter’s expertise and experience, does not reflect any official point of view. It represents the views of the presenter for the purposes of the First IGAD Member Countries Medicine Regulatory Authorities Conference on Regulatory Collaboration and Possibility of Harmonization, 3-5 August 2015, Hilton International Hotel, Addis Ababa, Ethiopia.

Outline Drug (Medicine) Discovery Process Medicines Quality Poor Quality Medicine Impact of Poor Quality Medicine National Medicine Quality Control Laboratory (NMQCL) NMQCLs in IGAD region Regional (IGAD) NMQCLs Network Conclusions Recommendations

Drug (Medicine) Discovery Process

Medicine Quality

Identity: Active ingredient (API)

Purity: Not contaminated with potentially harmful substances

Stability: Ensuring medicine activity for stated period

Potency: Usually 90–110% of the labeled amount

Bioavailability: Interchangeable products?

Uniformity: Consistency of color, shape, size

Identity, purity, potency, uniformity are defined in pharmacopoeias and stated in certificate of analysis (COA)

Determinants of medicine quality

How Is Medicine Quality Assured? Product Selection Acceptable stability, bioavailability, long shelf-life Selection of Suppliers Supplier pre-qualification Request on specific reports and data (e.g., bioavailability and stability studies) Information on supplier performance Product Certification GMP certificate of manufacturer Product/batch certification (COA) Random local testing

Medical products with poor quality are categorized as substandard/ Spurious/ Falsely-labeled /Falsified/ Counterfeit (SSFFC)

Substandard: Medicines that do not meet quality specificationsset for them (WHO) (excludes genuine manufacturing errors), but may include intentional, reckless or negligent errorsSpurious: Terminology used in South Asia for products falsely labelled or intended to deceive Falsely labelled: Includes genuine product with false packagingFalsified: European terminology to include a deliberate intention to deceive Counterfeit: Deliberate attempt to imitate a genuine product, focus on IPR. There is nouniversally agreed definition of counterfeit medicine (WHO)

Poor Quality Medicines

SSFFC: Substandard/Spurious/Falsely Labelled/Falsified/Counterfeit

Poor-Quality Medicines

Increased mortality and morbidity Cause drug resistance, loss of medicine efficacy Loss of confidence in health systems and health workers Economic loss for patients, their families, health systems, and the producers and traders in good-quality medicines Adverse effects from incorrect active ingredients (APIs) Waste of enormous human effort and finance in development of medicines, optimizing dosage, carrying out clinical trials, discussing policy change, and manufacturing medicines Increased burden for health workers, medicine regulatory authorities (MRAs), customs officials and police officers

Medicine quality Control Laboratories have the capacity to identify Poor quality medicines

Impact

Quality Control of Medicines

NMQCLs are public institutions which support regulatory authorities in controlling the quality of medical products for human and veterinary use as well as identify illegal medical products available on the market or intended to be on the market NMQCLs are separate and/or partially independent body from the Regulatory Agency

National Medicine Quality Control Laboratories

NMQCLs are prequalified for physical and chemical analysis of medicines and active pharmaceutical ingredients (APIs). The labs often have chemistry, microbiology and pharmacology units and are equipped with state- of-art equipment (eg. Chromatograph, Spectrometer, etc)

In order to assure continued reliability of generated results, the laboratory participates routinely in the WHO proficiency testing (PT) scheme which enables it to compare performance with other laboratories around the world NMQCLs play a key role in combating SSFFC products as they provide final evidence for adulterations of medicines

The work of NMQCLs has an impact on national, pan African and international legislation and on other anti-counterfeit initiatives

NMQCLs test (analysis) medicinal products independently from manufacturers (no conflicts of interest, guarantee of impartiality, respecting confidentiality).

National Medicine Quality Control Laboratory (NMQCL)

Medicine Quality Control (Laboratories) In Sub Saharan Africa (SSA)

Access to reliable medical products quality testing is inadequate in SSA region There are 5 WHO prequalified quality control laboratories exist in SSA region

Currently, 16 SSA countries are members of the Network of African Medicine Quality Control Laboratories (NAMCOL), established in 2009 Currently, 33 SSA countries are an official or associate member of the WHO Program for International Drug Monitoring (PIDM) Official Medicines Quality Control Laboratories of 4 SSA countries, (Ethiopia, Ghana, and Nigeria, and Kenya) have received ISO 17025 accreditation

Some Facts

ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories

Regional (IGAD) NMQCLs

ObjectiveProvide improved access to safe, effective and quality medicines in the IGAD region. A regional approach.

Analysis of substandard, counterfeit / illegal medicines (SSFFC) Pre-marketing sampling and analysis Post-approval (marketing) surveillance, sampling and testing Analysis of unlicensed (unauthorized) medicines Support in evaluation of the quality part of RA files Support of pharmacovigilance assessments Support of GMP inspections as experts Evaluation of quality defect reports

Roles:

(Experience from European, Official Medicines Control Laboratory, OMCL)

National Medicine Quality Control Laboratories (NMQCLs) in IGAD Region

Implementing comprehensive methods for analyzing the quality of drug samples, techniques to increase laboratory performance and improve drug analyses Promoting strategies and tools for increased data information sharing with laboratories, regulatory authorities and other national and international agencies Establishing and maintaining international accreditation Collaborate with customs, police, law court, health authorities in questions of identification of falsified/illegal medicines, eg. supporting forensic labs in complementary testing, acting as technical experts in trials Training of professionals on medicines quality testing

National Medicine Quality Control Laboratories (NMQCLs) in IGAD Region

Roles……….Cont’d

Regional (IGAD) NMQCLs Network

To promote the collaboration in the IGAD member countries in the area of quality control of medicinal products, identify SSFFC medicinal products and prevent them from reaching patients

Objective

Advantages: Increased expertise; pooling of know-how Organizing hands-on training for NMQCLs on substandard and counterfeit medicines testing Creation of centers of expertise as testing becomes more and more complex Cross border cooperation, e.g. to detect substandard, counterfeited, illegal or low quality medicines and quick info exchange

Create a unified voice for feedback and exchange with regulatory authorities, GMP inspectors, pharmacovigilance experts, manufacturers and other stakeholders Strengthen the performance and technical skills of NMQCL staffs Promote communication and the exchange of information Harmonize methodologies to facilitate acceptance/recognition Ensure compliance with Good Laboratory Practices (GLP) Establish collaboration with continental and others (eg. European OMCL net work, etc) Medicine Quality Control Laboratory networks and organizations or government bodies Environmental protection, “less waste by sharing work”

Regional (IGAD) NMQCLs Network

Advantages……..cont’d

Developing policies and rules (in collaboration with RAs), procedures and guidelines Develop human resources Initiate/create expert groups

Harmonized Quality Management Systems (QMS), ISO standard

Establishing drug quality surveillance programs within NMQCLs networking countries in order to control the quality of APIs and medicinal products available on the IGAD countries market Offers inter-laboratory testing activities for participating labs to improve laboratory performance

Regional (IGAD) NMQCLs Network

Tasks

Promotes common QMS in all NMQCLs to enable their work- sharing and mutual recognition of test results Scientific exchange on the level of working groups, plenary meetings and symposia Establishing common test programs and promoting advanced analytical testing method Mobilize concerted testing campaign Onsite medicine testing, eg. Minilab field testing kits SSFFC report, data pooled

Regional (IGAD) NMQCLs Network

Tasks……………cont’d Monitoring/checking the proficiency of the NMQCLs by PTS- like program and enhancing by training as well as harmonize their analysis methodologies

Harmonization of the testing activities by use of common standards, based on legal requirements Mutual recognition of test results Efficient cross-boarder, onsite testing, work sharing Simplified exchange of knowledge and expertise

Data exchange, establishing knowledge of database that provides linkage of information about SSFFC medicinal products generated by NMQCLs, customs, police and health authorities via a common database for regional NMQCLs networked countries A discussion platform for sharing scientific information and strategies Concerted activity of the NMQCLs through the NMQCLs network

Regional (IGAD) NMQCLs Network

Possible Goals:

Human Resources Advisory Group Plenum (decision) Expert Groups Secretariat (coordination)

Policies and Rules Terms of Reference Procedures Guidelines

Regional (IGAD) NMQCLs Network

Ref: EDQM (R wanko), www.edqm.eu

Foundation Pillars

Harmonized Quality Management System (QMS)On basis of the ISO/IEC 17025 standard

Educational Programs• Technical, QMS training &

curriculum development• Training on IT tools

• Training visits to laboratories

IT Platforms • IT (dissemination of information,

documents, reports…)• Databases (exchange of information

on technical competencies, testresults…)

Surveillance of the Quality Management Systems (QMS)• Programs to support the implementation of QMS

• Audit program (equivalent to accreditation)• Proficiency Testing Studies (PTS)

• Quality guidelines to complement ISO17025

Regional (IGAD) NMQCLs Network

Coordination Tools

Ref: EDQM (R wanko), www.edqm.eu

Conclusion The overall quality of a medical product in the IGAD region, relies upon a number of approaches where the analytical experience and capability of NMQCLs plays a critical role Independent and active pre marketing sampling and analysis and post-marketing surveillance, sampling and testing by the individual NMQCLs is fundamental Strong cooperation between NMQCL experts, quality assessors, GMP inspectors is critical for the common goal of a better quality and more controlled drugs and medical products A strategy for establishment of a network of NMQCLs in IGAD countries is of great advantage for the surveillance, identification and control of SSFFC medical products and also in building testing capacities of individual NMQCLs

Conclusion..…….cont’d Regional (IGAD) NMQCLs network can play critical role in building testing capacities of individual NMQCLs Human resource capacity building Harmonization of testing methodologies, mutual recognition of test results Medicine quality control tests at cross boarder sites utilizing simple and mobile testing technologies (eg. Minilabs,..) is vital Participating in WHO’s prequalification programs and meeting standards commended is critical NMQCLs should be of high standards, with updates technologies, skills and efficient collaboration/networking

Promoting medicine quality control laboratories in all IGAD member countries, establishing new and, strengthening existing laboratories QMS: Building capacity of medicine quality assurance QA and QC systems in all IGAD member countries (joining WHO prequalification program, international accreditation, ISO 17025) Creating regional medicine quality control laboratories network between IGAD member countries Creation of Regional Center of Excellence (RCoE), center of expertise, reference and training center for NMQCLs Participating in Regulatory Science Education

Recommendations

Creating expert (working) group (Task force, coordination body) facilitated by IGAD with active participation of member states and key partners

SSFFC medical products are “silent weapons” killing several hundred thousands of innocent

patients every year, can be controlled & prevented!

A shared responsibility!

Thank You for Your Attention!Thank You for Your Attention!