Transcript Document

FEEDBACK ON AFRICA
REGULATORY CONFERENCE
FEBRUARY 2008
13/06/2008
SAPRAA-Salma Ismail
TOPICS ADDRESSED:
 The Importance of Pharmaceutical R&D
 Role of Africa in Clinical Development – Regulatory Implications
 Accelerating Access of Medicines to Address Diseases of
PublicHealth Importance
 EU Regulatory Assessment Using Article 58
 WHO Prequalification Scheme
 Biosimilars
 Update on ICH-GCG and Interface with Regional Harmonisation
Initiatives
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TOPICS ADDRESSED:
Experience and Successes of EU Accession
Update on SADC Including the Perceived Benefits and Challenges of
Harmonisation
ICH Quality
Quality Risk Management
GMP and the Pharmaceutical Inspection Cooperation Scheme
Journey into PIC/S
 WHO Certification Scheme
The Place of the CPP in Guaranteeing Quality, Safety, and Efficacy
The Roles of the WHO IMPACT Groups
Industry Perspective of Counterfeits – Regulatory Implications
Addressing the Counterfeit Issue
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Update on SADC Including the
Perceived Benefits and
Challenges of Harmonisation
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The Southern African
Development Community
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Angola,
Botswana,
Democratic Republic of Congo,
Lesotho,
Madagascar (membership pending),
Malawi,
Mauritius,
Mozambique,
Namibia,
Seychelles,
South Africa,
Swaziland,
Tanzania,
Zambia and
Zimbabwe.
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SADC OBJECTIVE:
• To build a Region in which there will be a high
degree of harmonization and rationalization to
enable the pooling of resources to achieve
collective self-reliance in order to improve the
living standards of the people of the region.
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HARMONIZED PHARMACEUTICAL PROGRAMME
• implement a harmonized Pharmaceutical
Programme -SADC Health Protocol and the
SADC Health Policy.
• Programme purpose:
– to enhance the capacities of Member States to
effectively manage diseases and medical conditions
that are of major concern to public health in the
Region such as HIV and AIDS, TB, Malaria and other
communicable diseases.
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SADC CHALLENGES:
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numerous challenges related to Harmonizing the Regulation of
Medicines.
different stages of development in terms of regulatory capacities in the
Region
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some regulatory authorities have more advanced systems than others.
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setback due to the emergence of:
– multidrug resistant Tuberculosis
– high incidences of the HIV and AIDS;
– prevalence of resistant malaria parasites to affordable medicines;
– and resistance of mosquitoes to insecticides.
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fight against proliferation of substandard and counterfeit medicines
within the Region.
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The Region has not been spared in terms of human resource for health
constraints due to brain drain.
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SADC GUIDELINES HAVE NOW BEEN
FINALIZED & APPROVED
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Registration of medicines
Licensing of pharmaceutical establishments;
Licensing for export / import;
Post-marketing surveillance;
Medicines Donations;
Recalls,
Stability and Validation;
Biavailability/bioequivalence
Advertising and promotion of medicines;
Clinical trials; and
Nutritional supplements
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CONTACT
• Joseph Mthetwa
Senior Programme Manager for Health and Pharmaceuticals
Directorate for Social and Human Development and Special
Programmes
Southern African Development Community Secretariat (SADC)
Kgale View Offices
Private Bag 0095
Gaborone
Botswana
Tel:
+267 3951863
Fax:
+267 3972848 / +267 3181070
Mobile: +267 71720972
E-mail: [email protected]; or [email protected]
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WHO Certification Scheme
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The WHO Certification Scheme
• Is an administrative tool developed in response to the
requests of WHO Member States
• Is a voluntary/non binding agreement between WHO
Member States
• Is information exchange mechanism on the quality of
imported drugs
• Is intended to give assurance to countries that are
importing pharmaceutical products but have no
capacity or limited capacity to assess the safety,
efficacy and the quality of the drugs they import
• Is intended to facilitate availability and trade in
pharmaceuticals by ensuring safety, efficacy and
quality
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Three types of certificates are
issued under the current Scheme
• Certificate of a Pharmaceutical Product
(Product Certificate) or CPP
• Model Batch Certificate of a
Pharmaceutical Product
• Model Statement of Licensing Status of
Pharmaceutical Product (s)
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Issuing a certificate
• The certifying authority is responsible for assuring
the authenticity of the certified data.
• Certificates should not bear the WHO emblem, but a
statement should always be included to confirm
whether or not the document is issued in the format
recommended by WHO.
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Advantages of the Scheme:
• It uses standard format
• It can enable importing countries to get all the
information they need to know about the
product they import
• It can enhance the exchange of information
between countries and can lead to
harmonisation of information
• It can oblige certifying authorities to disclose
important information to the importing country
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Limitations of the Scheme
• Rely on the honesty and competence of
the issuing authorities
– A certificate is as good as the certifying
authority
• Requirements differ in countries for MA
– More applies to generic drugs?
• Counterfiet certificates reality
– Sample of fake logo from web site
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WHO’s recommendation
• Communicate directly with the issuing
authorities to build confidence and
trust
• Contact the certifying authority and ask for
the duplicate of the certificate to be sent
directly, if in doubt
• Seek assistance from WHO
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Problems
• Consistency with WHO Certification Scheme
– WHO format not adopted in all issuing countries,
authorities continuing to issue Free Sales Certificates
e.g. France
• Embracing the Spirit of the Scheme by Issuers
and Recipients
– CPPs cannot be issued if the product is not exported
from the country (but does have MA)
– Receiving countries do not accept CPPs for products
that are not marketed in the issuing country
• Long delays in issuance of CPPS
• Excessive demands from recipients…
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What are the issues?
• Can all national regulators assess and inspect
all the new innovative products that come to
their markets?
• Does repetitive assessment and inspections give
added value?
• How to build confidence in scientific
assessments carried out by other parties?
• How regulators can best contribute to the public
health with the resources they have?
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What is a Free Sale Certificate?
• issued by the national health authorities
• product specific
• States product is for "free sale" within the
country of origin.
• the product is not necessarily licensed/ the
product is of a quality suitable for being placed
on the market.
• does not guarantee that the product in question
is marketed in the country of origin.
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What is a CPP (Certificate of
Pharmaceutical Product)?
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issued by the national health authorities-request from
– manufacturer,
– customer or
– authorities in the importing country.
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product specific
states whether or not the product is marketed in the country of origin.
states that manufacturer of product complies with GMP and that they are
inspected regularly by the national health authorities.
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The World Health Organization (WHO)- standard format for this type of
certificate and recommends that this format is used instead of the Free Sale
Certificates.
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A CPP (WHO format) generally covers the need for overall documentation
regarding the product as well as the manufacturer. It should therefore not be
necessary to request any of the certificates mentioned above. The
certificate is also called a WHO certificate.
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CPP has two DISTINCT parts
– Evidence of Positive Quality, Safety and
Efficacy (QSE) Review
assurance of QSE without the cost and time
of a large local regulatory infrastructure
– Evidence of Compliance with Good
Manufacturing practice (GMP)
Certification of GMP for issuing country’s
sourcing route
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WHO Prequalification Program
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PREQUALIFICATION PROGRAMME
A United Nations Programme managed by WHO
• Vision
Good quality medicines for everyone.
• Key output
• The list of prequalified medicinal products:
– HIV/AIDS, malaria, tuberculosis and for reproductive health
produced by the Programme is used principally by United
Nations agencies — including UNAIDS and UNICEF — to guide
their procurement decisions.
– the list -a vital tool for any agency or organization involved in
bulk purchasing of medicines, be this at country level, or at
international level, as demonstrated by the Global Fund to Fight
AIDS, Tuberculosis and Malaria.
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Is quality of medicines still a big problem?
• Panama case in 2006. It turned out the cause of
death of more than forty five persons was simple.
The cough syrup and potentially other medicines
produced in the governmental pharmaceutical
factory were contaminated.
• The death were caused by diethylene glycol (DEG)
found in medicines. DEG is a chemical cousin of
antifreeze and used widely by various industries. It
is toxic to the kidneys and can cause deadly renal
failure.
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How it works
• Any manufacturer wishing their medicines to be included in the
prequalified products list are invited to apply.
• present extensive information on the product (or products)
submitted to allow qualified assessment teams to evaluate its
quality, safety and efficacy.
• The manufacturer: open its manufacturing sites to an
inspection team which assesses working procedures for
compliance with WHO Good Manufacturing Practices (GMP).
• Alternatively, the inspections carried out by stringent
regulatory bodies are recognized and their work is not
duplicated by WHO.
• assessment teams: include experts from some of the national
regulatory authorities of the European Union as well as Canada
and Switzerland.
• The prequalification process takes a minimum of three months
if the product meets all the required standards.
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Assessment procedure- Product
dossiers
 Innovator products
• Abridged procedure if approved by stringent authorities like EMEA and
US FDA
• Assessment reports from Drug Regulatory Authorities (DRSs), WHO
Certificate of Pharmaceutical Product (CPP), batch certificate, update
on changes
• Trusting scientific expertise of well-established DRAs
 Multisource products
• Full dossier with all data and information requested
• Quality : information on starting materials and finished product
including API details, specifications, stability data, formulation,
manufacturing method, packaging, labelling etc
• Efficacy and safety: Bio-equivalence study or clinical study report
• US FDA tentative approvals for ARVs – recognition scientific assessment
based on information exchange (Confidentiality agreement between US
FDA and WHO); the same approach apply for EU Art 58 and Canadian
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JCPA procedure)
The list of medicines
• Medicines which have been found to
meet the required standards
• In soliciting applications from
companies, WHO does not
question whether the products
presented are patented or generic,
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Why the prequalification is needed?
 Risks
• Sourcing of poor quality products or even counterfeit medicines
 risk to patients, toxic reactions, treatment failure, resistance
 bad quality (generic) products undermine public confidence
 Problems
• Millions of people living with HIV/AIDS, tuberculosis and malaria,
have no or limited access to treatment
• Substandard and counterfeit products in different countries
• Weak or absent QA systems of medicines supply chain
• Lot of money invested in procurement
products with very different quality sourced
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Article 58 EMEA's Scientific Opinion
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European legislation (Regulation 726/2004) excluded licensure of vaccines and
other medicinal products for exclusive use outside the European Community.
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concern since licensure of priority vaccines for developing countries would
become the responsibility of the national regulatory authorities (NRAs) of user
countries, which, in the past, relied on the regulatory evaluation of the NRA of
the country of origin to assure quality.
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To ensure no disruption in the supply of vaccines and medicinal products that
are important for developing countries a consultation and collaboration
between EMEA and WHO led to the Article 58 in the new Regulation.
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Article 58 establishes a mechanism whereby the EMEA may give a Scientific
Opinion, in the context of cooperation with WHO, for the evaluation of certain
medicinal products for human use intended exclusively for markets outside the
Community. The procedure for implementation of Article 58 Scientific Opinion
procedure, effective since May of 2005 begins with the request from the
company to EMEA to assess the eligibility of the product for Scientific Opinion.
WHO's input takes place in two instances:
evaluation of eligibility of the vaccine for Scientific Opinion by EMEA;
participation of experts proposed by WHO in the product evaluation process.
So far, one vaccine has gone through the review by WHO and deemed eligible
for Scientific Opinion. There is indication that a few more vaccines will follow
shortly.
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IN CONCLUSION
It's not enough to have lived; we should
be determined to live for something.
May I suggest that it be creating joy for
others,
sharing what we have for the betterment
of personkind,
bringing hope to the lost and love to the
lonely.
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