Medicines Regulation: Introduction
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Transcript of Medicines Regulation: Introduction
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Department of Essential Medicines and Pharmaceutical Policies
Medicines Regulation: Introduction
Dr Lembit RägoCoordinator
Quality Assurance and Safety: MedicinesEssential Medicines and Pharmacutical Policies
World Health OrganizationGeneva, Switzerland
E-mail: [email protected]
EMP Technical Briefing Seminar, November 2011
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Department of Essential Medicines and Pharmaceutical Policies
Medicines work in WHO HQ – in Health Systems and Services Cluster (HSS), ADG Dr Carissa Etienne
Department of Essential Medicines and Pharmaceutical Polices (EMP) Two teams
Medicines Access and Rational Use (MAR) Quality Assurance and Safety: Medicines (QSM)
Two units (teams) attached to Director's office Medicines Information and Evidence for Policy (MIE) Medicine Programme Coordination (MPC)
Collaboration with other clusters/departments/units Vaccines and biologicals (IVB/QSS) – vaccines prequalification Essential Health Technology (EHT) - diagnostics prequalification Disease oriented programs Other programs …
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Department of Essential Medicines and Pharmaceutical Policies
Active collaboration with other international, regional and national organizations
UN family & international organizations: UNICEF, UNFPA, UNIDO etc. MSF
Regional Council of Europe/EDQM EMA/EU NEPAD
Professional and scientific FIP, IUPHAR, ISPE
National NMRAs
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Department of Essential Medicines and Pharmaceutical Policies
QSM Technical Programmes
Regulatory Support International Nonproprietary Names (INNs) Quality Assurance Anticounterfeiting Safety (Pharmacovigilance) Prequalification of Medicines Quality Assurance and Safety of Blood Products and
Related Biologicals
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Department of Essential Medicines and Pharmaceutical Policies
Why medicines are special category of products?
Consumers, patients and health care workers have limited capacity to judge there
SAFETY QUALITY EFFICACY
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Department of Essential Medicines and Pharmaceutical Policies
SmellAppearance Taste
Usual perceptions may not help in Making judgements about medicines …
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Department of Essential Medicines and Pharmaceutical Policies
Are all medicines safe, effective and meet quality criteria?
No, they are not
Some are safe, but not effective or necessarily meet the quality criteria
Some may be effective, meet quality criteria but are not safe
Some meet quality criteria but are not necessarily safe or have any efficacy
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Department of Essential Medicines and Pharmaceutical Policies
Quality - Safety
Some safety parameters are determined by quality
Some safety parameters are determined by the intrinsic properties of active pharmaceutical ingredient(s)
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Department of Essential Medicines and Pharmaceutical Policies
What type of medicines we have?
Originator products Multisource (generic) products
KEY – INTERCHANGEABILITY, more important THERAPEUTIC INTERCHNGEABILITY
ALL LITERATURE IS BASED ON ORGINATORS No interchangeability – NEED FOR NEW SAFETY and
EFFICACY DATA, NEW BOOKS HAVE TO BE WRITTEN
Other type of products Biological products including vaccines and blood products "Biosimilars" Radiopharmaceuticals Traditional medicines
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Department of Essential Medicines and Pharmaceutical Policies
What type of regulations exist and how they differ?
For innovator products proof of QUALITY, SAFETY and EFFICACY is needed
For multisource products QUALITY, safety and efficacy data is referred to the originator providing only evidence about interchangeability (bioequivalence, clinical testing, in limited cases dissolution data)
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Department of Essential Medicines and Pharmaceutical Policies
Regulations: Global vs National
National regulations still differ a lot
What is ICH and what it is not?
Regional harmonization initiatives
Do global norms exist for generics?
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Department of Essential Medicines and Pharmaceutical Policies
In book: Drug Benefits and Risks, Chapter 6, 2008
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Department of Essential Medicines and Pharmaceutical Policies
Main regulatory functions
Table 1. Principal medicines regulatory functions• Licensing of the manufacture, import, export, distribution,promotion and advertising of medicines• Assessing the safety, efficacy and quality of medicines,and issuing marketing authorization for individualproducts• Inspecting and surveillance of manufacturers, importers,wholesalers and dispensers of medicines• Controlling and monitoring the quality of medicineson the market• Controlling promotion and advertising of medicines• Monitoring safety of marketed medicines includingcollecting and analysing adverse reaction reports• Providing independent information on medicines toprofessionals and the public
Source: WHO Policy Perspectives on Medicines no 7, 2003.
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Department of Essential Medicines and Pharmaceutical Policies
Is quality of medicines a problem?
Yes, a HUGE problem
If we would have the same compliance with norms and quality in aircraft industry Globally
approximately 25% planes would not take off the grounds
10% would crash and kill the people (treatment failure = killing in some cases; toxicity etc. )
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Department of Essential Medicines and Pharmaceutical Policies
Quality can not be assessed, tested or inspected into the product, BUT
It has to be built into it!!
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Department of Essential Medicines and Pharmaceutical Policies
Shifting the regulatory paradigm during the history (1)
From elementary quality requirements to safety and efficacy
From quality control of finished product to control of quality of manufacturing (inspection)
From quality control of finished product and inspection of manufacturing sites in general to more understanding the processes and product specific processes involved
From rigid limits to agreed upon beforehand set of limits which can be used by manufacturers in a more flexible manner (ICH QbD)
…..
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Department of Essential Medicines and Pharmaceutical Policies
Shifting the regulatory paradigm during the history (2)
Increased role of science – new molecules, new advanced therapies and combination therapies (device + medicine, etc)
From national to international – not a single regulator today can work meaningfully in isolation and not using other regulators experience/knowledge/information
Increasing need to decide what regulatory functions to fulfil nationally and what expertise/capacities to build nationally
Increasing need for harmonization, collaboration and cooperation The future in medicines regulation is in effective collaboration
and cooperation
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Department of Essential Medicines and Pharmaceutical Policies
Science and medicines regulation (example): European Medicines Agency (EMA) - First Scientific Workshop On Nanomedicines, 2-3 September 2010, London
Emerging therapies such as nonomedicines give rise to questions on the appropriateness of current regulatory frameworks, the relevance and adequacy of existing requirements and guidelines, and on the availability of adequate expertise to regulators.
Scientific challenges arise from the limitations of current testing methods and the reliability of novel ones, because of the 'nanosize' and the unique behaviour of such nano-systems in biological structures.
Examples of approved nonomedicines: the anti-neoplastic agent Caelyx includes stealth liposomes of doxorubicine
hydrochloride; the antineoplastic agent Mepact contains mifamurtide in multilamellar liposomes; the antineoplastic agent Abraxane contains paclitaxel nanoparticles bound to human
serum albumin; the immunosuppressant Rapamune contains sirolimus particles in nanocrystal
colloidal dispersion.