Transcript Medicines Authority

Medicines Authority
Harmonisation of
Medicines Regulatory
Affairs
Medicines Authority
203,Level 3,
Rue D’Argens,
Gzira,GZR 1368
Tel: (+356) 2343 9000
Fax: (+356) 2343 9161
Email: [email protected]
Anthony Serracino Inglott
Chairman of the Malta Medicines Authority
Regulatory Harmonisation
Achieving a common public health goal
•Technical guidelines
• Uniformity
• Participation of all stakeholders
• Convergence-based approach
• Similar
• Aligned
• Standard and scientific principles
• Similar practices and procedures
• Technical guidance documents
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Regulatory Harmonisation
• International recognised standards
• Quality
• Safety
• Efficacy
• Global approach to the treatment of medicines with dignity as
distinct from ordinary items of commerce.
• World heritage of mankind.
• Increase access to internationally certified medicines.
• Tool towards a declaration by the United Nations that access
to medicines certified to international standards is a human
right.
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Regulatory Harmonisation
•Harmonisation goes further than development of
common documentation
• Building competence and trust
• Communication and collaboration
Collaborative approaches to drug registration
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Regulatory Harmonisation
What can we do to increase
access to new medicines whilst
ensuring consistent standards for
Quality, Safety and Efficacy?
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Regulatory Harmonisation
Access
Sharing
resources
Collaboration
Duplication
Regulatory
sciences expenses
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Regulatory Harmonisation
• Benefits of Regulatory Harmonisation
• Standardisation of documentation
• Format
• Content
• Improve the capacity of regulators.
• Bring new therapies to patients faster and at lower cost.
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Why regulating drugs?
• 1930s United States: a tragic mistake in the formulation of
sulfanilamide elixir
• 1960s Europe: thalidomide tragedy
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Pharmacopeias
The quality of medicines was established through the
development of the Pharmacopeias which lead to:
• Harmonised specifications for substances of different
origins
• Transparent monographs
• Specifications and valid analytical working methods
• Common Reference Substances
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Pharmacopeias
1820: United States Pharmacopoeia
Latest edition USP 39-NF 34 (November 2015)
1864: British Pharmacopoeia
Latest edition BP 2016 (August 2015)
1886: Japanese Pharmacopoeia
Latest edition JP 16 (2011) issued by Pharmaceuticals and Medical Devices
Agency
1951: The International Pharmacopoeia
Latest edition 5th Edition (2015) issued by WHO
1964: European Pharmacopoeia
Latest edition Ph.Eur. 8th Edition issued by the European Directive for the
Quality of Medicines
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GLOBAL
HARMONISATION
INITIATIVES
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International Harmonisation
• April 1990 - International Conference on Harmonisation
• International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human use (ICH)
• Regulatory authorities and pharmaceutical industry
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ICH Steering Committee
WHO – World Heath Organisation
EU – European Union
EFPIA – European Federation of
Pharmaceutical Industries and Associations
MHLW – Ministry of Health, Labour and
Welfare, Japan
JPMA - Japan Pharmaceutical
Manufacturers Association
FDA – US Food and Drug Administration
PhRMA – Pharmaceutical Research and
Manufacturers of America
IFPMA – International Federation of
Pharmaceutical Manufacturers and
Associations
Source: ICH website www.ich.org
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International Harmonisation
Objectives of ICH
•Increase international harmonisation of technical requirements.
• To improve efficiency of new drug development and registration
process.
• To promote public health, prevent duplication of clinical trials in
humans and minimise the use of animal testing without compromising
safety and effectiveness.
Accomplished through the development and implementation of
harmonised guidelines and standards.
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ICH Guidelines
Q - Quality; S - Safety; E - Efficacy; M - Multidisciplinary
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Source: ICH website www.ich.org
ICH Outcomes
Over 80 guidelines on technical requirements on:
• Efficacy - 9 topics/ 20 guidelines (E3 Structure and content of
Clinical Study Reports
• Safety - 9 topics/18 guidelines (S1 Rodent Carcinogenicity Studies
for Human Pharmaceuticals)
• Quality - 10 topics/41 guidelines (Q1A (R2) Stability testing of New
Drug Substances and Products
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ICH Outcomes
Multidisciplinary Guidelines
• Medical dictionary for adverse event reporting and coding of clinical trial data
(MedDRA)
• Electronic Standards for the Transfer of Regulatory Information
• Non clinical safety studies for the conduct of human clinical trials and marketing
authorisation for pharmaceuticals – M3 (R2)
• Common Technical Document (CTD & eCTD)
• Data elements and standards for drug dictionaries – M5
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CTD organisation in Modules
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Source: ICH website www.ich.org
International Collaboration on
GMP inspection
Greater international collaboration and information sharing to help to
better distribute inspection capacity allowing more sites to be
monitored and reducing unnecessary duplication.
80% of all active pharmaceutical ingredients (API) used in Europe comes
from other countries.
Joint API inspections pilot programme (2008–2010) was a success among
the participating authorities
• The reference GMP standard for the inspections is ICH Q7
• Sharing of inspection plans and outcomes for such inspections
carried out or proposed to be carried out.
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International Collaboration on
GMP inspection
Co-ordination of GMP inspections – Finished Dosage Forms
Coordination of inspections of manufacturers in third
countries among EU national competent authorities.
India and China are significant manufacturing sources
1 in 2 of EU third country inspections are carried out in India
and China
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International Collaboration on
GMP inspection
The geographical location of the foreign inspections carried out by EEA competent authorities
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Source: Luigetti R. et al. GMP Oversight of Medicines Manufacturers in the European Union. PDA Letter. Sep 25, 2015
International Collaboration on
GMP inspection
Malta’s contribution in third-country GMP inspections
March 2014: Malta’s first third-country GMP inspection
To date: Malta has carried out 11 third-country GMP inspections
in India and Serbia
Advantages of Malta:
• Strategic position
• Flexible regulatory authority
• Highly Efficient
• Professional trained staff
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International Collaboration on
GMP inspection
EMA/FDA inspection programme for finished-dosage-form
manufacturers – pilot programme initiative launched in January 2012
• Share work on inspection of manufacturing sites.
• This enables the two authorities to rely on each other’s
inspection outcomes rather than carrying out separate inspections
in duplicate.
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International Collaboration on
GMP inspection
EudraGMDP database to improve sharing of information
• Access to all EU and EEA Member States
• Several international regulatory partners have unrestricted
read and write access to the database including those with
mutual recognition agreements.
• October 2013 Japanese regulatory authorities were the
first to start entering information into this database.
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Drug Development
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Shift to Biopharma
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Biotech – Health care Challenge
Big annual cost for biologics
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Patient access to innovation:
Biosimilars
Biosimilars is defined as “a biological medicinal product
that contains a version of the active substance of an
already authorised original biological medicinal product.
A biosimilar demonstrates similarity to the reference
medicinal product in terms of quality characteristics,
biological activity, safety and efficacy based on a
comprehensive comparability exercise.”1
1. Guideline on similar biological medicinal products. European Medicines Agency. CHMP/437/04 Rev 1. 23 October 2014
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More than $60 billion worth of patents on
biological products are expiring before 2020
This figure shows the number of biosimilars clinical trials started between 2007 and 2014
Source: Boren J. Et al. Challenges in Global Biosimilar Development: A Regulatory Perspective. Contract Pharma June 2015
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Patent expiration of biologicals
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Source: Kumar R., Singh J. Biosimilar drugs.. Current status. Int J Appl Basic Med Res. 2014 Jul-Dec; 4(2): 63–66.
Biosimilars are not generics
This figure shows the differences between small molecule drugs and biopharmaceuticals.
Source: Advantage, A. S. H. P. "A Health-System Pharmacist’s Guide to Biosimilars: Regulatory, Scientific, and Practical
Considerations." Continuing Education Study Guide. http://ashpadvantagemedia. com/downloads/biosimcentral_guidelines. pdf.
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Challenges with biosimilars
• Manufacturing complexity
• Clinical safety and immunogenicity profile
• Post marketing pharmacovigilance
• Establishing biosimilarity
• Interchangeability and substitution
• Willingness of physicians, payers and patients to
adopt biosimilars
• Education - pharmacists play an important role
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Need for harmonisation
Simpler
communication
Variability
Access to
patients
Sharing of
Information
Efficiency
Costs
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Innovative Medicines Initiative
• Public private partnership established by the EU and EFPIA
• Aims to improve pharmaceutical innovation for the benefit of
consumers
• Enhance competitiveness of the health sector in Europe
• Serve as a European engine for regulatory science
• To translate scientific results into the regulatory framework at
global conferences in order to align regulatory requirements.
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If you want to go fast go alone
If you want to go far go together
African proverb
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Thank You