Caribbean reg system · ∗ The CRS is a centralized regulatory mechanism intended to speed...
Transcript of Caribbean reg system · ∗ The CRS is a centralized regulatory mechanism intended to speed...
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The Caribbean Regulatory System Copenhagen 2017Presented by Charlie Preston, MD, MPH
Advisor, Regulatory Systems Strengthening, PAHO/WHO
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∗ Orient industry to a new regulatory mechanism in the CARICOM block of countries
∗ May be a good business opportunity
∗ Combines many of the elements industry says it wants:
∗ Harmonization
∗ Reliance
∗ Accelerated processing
∗ Accountability
∗ Transparency
Title of the Presentation 1
Purpose of This Presentation
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CARICOM Map
*Member States are:
Antigua and Barbuda, Bahamas, Barbados,
Belize, Dominica, Grenada, Guyana, Haiti,
Jamaica, Montserrat, Saint Lucia, St. Kitts and
Nevis, St. Vincent and the Grenadines,
Suriname, and Trinidad and Tobago
*Associate Member States are:
Anguilla, Bermuda, British Virgin Islands,
Cayman Islands, and Turks and Caicos Islands
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∗ The CRS is a centralized regulatory mechanism intended to speed marketing authorizations/legal sale of quality essential medicines in CARICOM
∗ It helps CARICOM states perform assessments of essential medicines/vaccines for legal sale, and 2) monitors medicines in the market
∗ It is physically a regulatory unit, with small # staff, based at CARPHA, with technical cooperation by PAHO/WHO, funded by Bill and Melinda Gates Foundation
∗ Derives from Caribbean Pharmaceutical Policy and endorsement by CARICOM Ministers of Health in 2014
∗ Small countries struggle with individual regulatory capacity but have strong history of cooperation and goal of common market
∗ The mechanism is voluntary and is not meant to replace national systems
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What Is the CRS?
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∗ To use the mechanism, medicine must be:
∗ Essential medicine listed on WHO list (2017) (innovators and generics)
∗ Be approved in 1/10 PAHO designated authorities of reference: Argentina, Brazil, Canada, Chile, Colombia, Cuba, European Union, Mexico, United States, and WHO Prequalification
Title of the Presentation 4
Eligibility: CRS Mechanism
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∗ Company prepares a dossier based on same procedure WHO uses to prequalify products already approved by SRAs
∗ Manufacturer signs cover letter saying product is same
∗ Focus of CRS assessment is verification that the product is the same∗ Takes about 6-8 weeks to assess
∗ Much faster than current situation in many countries
Title of the Presentation 5
Process: CRS Assessment
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∗ Broadly, these include the following: ∗ Cover letter that product is the same as in reference
country; demonstration of marketing authorization certificate; summary product characteristics; labelling; GMP certificates from reference authority; batch certificate of analysis; finished product specifications; proof of therapeutic equivalence; stability studies; periodic safety update report; portions of quality information summaries
∗ Don’t require CPP, product samples, or pre-testing
Title of the Presentation 6
Dossier Submission Requirements
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∗ Can accept prior documentation submitted to reference authority, e.g. CTD, other summary formats
∗ Happy to try different approaches as long as basic requirements are met
∗ Want to reduce burden on company
∗ No user fees right now
∗ Uses WHO collaborative procedure for medicines and vaccines
Title of the Presentation 7
Dossier Submission Requirements
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∗ If CRS assessment/verification is favorable, CRS recommends the product to all of CARICOM for marketing authorization/import permit/procurement
∗ 6 countries have marketing authorization for products: Belize, Guyana, Haiti, Jamaica, Suriname, Trinidad and Tobago
∗ OECS has a regional procurer called OECS/PPS
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Process: CRS Assessment
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∗ To accompany recommendation, CRS issues an Assessment Report to CARICOM governments∗ Government decides whether to grant approval
∗ Target is 60 calendar days
∗ General in-country uptake process∗ Fill out local administrative forms (regulatory info
covered by Assessment Report)
∗ Pay local user fee
∗ Identify local importer
Title of the Presentation 9
Process: In-Country Uptake
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CARPHA/CRS Assessment Process
Company
In-CountryProcess (MOH) (Target: 60 calendar days)• Fill out local administrative forms• Pay local user fee• Identify a local importer
CARPHA/CRSAssessment/Verification (30- 60 days)
Marketingauthorization/import permit
Recommendation/ Assessment Report
Dossier submitted and under assessment
Eligibility for CRS Assessment• Essential/ priority med +• Approved by RA
CARICOM Governments
Other opportunities, e.g. accelerated qualification for procurement, etc.
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∗ After only a year and a few months of staff on the ground, the CRS initiative is progressing well!
∗ It has recommended 11 essential HIV products to CARICOM governments
∗ Other products in the queue including for NCDs
∗ CRS is building a portfolio of essential medicines that governments can grant marketing authorization/import permit and procure
Title of the Presentation 11
Current Status: Achievements
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CARPHA/CRS List of Medicines Recommended for Marketing Authorization in CARICOM States
List of regulatory assured medicines that governments can use for marketing authorization/import permit and procurement
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CARPHA/CRS:
CRS/022017/HA001;
WHO: HA 291
Lamivudine/Zid
ovudine HIV/AIDS;
Strides Shasun Ltd, Strides
house, Bilekahali,
Bannerghatta Road,
Bangalore, 560 076, India Tablet
2
CARPHA/CRS:
CRS/032017/HA002;
WHO: HA 535
Tenofovir
Disoproxil
Fumarate
HIV/AIDS;
Hepatitis B
Strides Shasun Ltd, Strides
house, Bilekahali,
Bannerghatta Road,
Bangalore, 560 076, India Tablet
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CARPHA/CRS:
CRS/042017/HA004
WHO: HA 524
Lamivudine,
Nevirapine and
Zidovudine USP
[150/200/300m
g] Tablets HIV/AIDS;
Strides Shasun Ltd, Strides
house, Bilekahali,
Bannerghatta Road,
Bangalore, 560 076, India Tablet
4
CARPHA/CRS:
CRS/0517/HA005
WHO: HA 552
Emtricitabine/T
enofovir
Disoproxil
Fumarate
[200/300mg]
Tablets HIV/AIDS;
Strides Shasun Ltd, Strides
house, Bilekahali,
Bannerghatta Road,
Bangalore, 560 076, India Tablet
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∗ Drug safety and monitoring
∗ Launched regional mechanism for pharmacovigilance and post market surveillance (VigiCarib)
∗ Country focal points report adverse and substandard/falsified medicine events to CRS for analysis and recommendations to Member States
∗ Leverages regional CARPHA lab for risk based drug testing
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Other Achievements
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∗ Helping to reorient country regulatory approaches
∗ Memorandums of understanding with Anguilla, Guyana, OECS PPS, Suriname
∗ Guyana and Jamaica initiated fast-track process for CRS recommended products- close to approval in Guyana, 5 tentatively approved in Jamaica
∗ Accelerated qualification for procurement in Barbados, OECS
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Other Achievements
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∗ Still implementing country uptake
∗ Invite industry and distributors to be patient, advocate for governments to use this mechanism∗ Eligible products are all those on EML, including
innovators (something for everyone)
∗ Nature of effort will look like small incremental gains in short term, but will add to major advances in medium to long term� needs long term political commitment
Title of the Presentation 15
Challenges
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∗ Major industry opportunity with this mechanism∗ Harmonization, reliance, accelerated review, accountability,
and transparency
∗ New to market; want to launch new product quickly; want to expand to other markets, etc.
∗ No user fees now, want to stabilize the system
∗ Wide variety of products to submit, will participate in WHO Collaborative Procedure pilot with biosimilars (can consider products not on EML if need)
∗ Will help you obtain volume, pricing information
Title of the Presentation 16
Summary: Why CRS?
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∗ For more information, visit the CARPHA/CRS webpage: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS
∗ Additional information and submission inquiries can be requested from the below:
Thank You