WHO's perspective IMDRF meeting 20 March 2013, Nice, France Kees - - PowerPoint PPT Presentation

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Nov 14, 2022 285 likes •427 views

Regulatory convergence WHO's perspective IMDRF meeting 20 March 2013, Nice, France Kees de Joncheere Director Department of Essential Medicines & Health Products 1 | 3 rd IMDRFmeeting, Nice | 20 March 2013 Epidemiological Changes:

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1 | 3rd IMDRFmeeting, Nice | 20 March 2013

Regulatory convergence WHO's perspective

IMDRF meeting 20 March 2013, Nice, France Kees de Joncheere Director Department of Essential Medicines & Health Products

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2 | 3rd IMDRFmeeting, Nice | 20 March 2013

Epidemiological Changes: increasing NCDs

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3 | 3rd IMDRFmeeting, Nice | 20 March 2013

World Health Organization

 194 member countries  WHO mandate:

– Norms and standards for medical products – To promote improved access to safe and quality medical products

 World Health Assembly:

– maximum governing body – 60TH World Health Assembly , 23 May, 2007 approved resolution WHA60.29:

WHA60.29 “ to draw up Regional guidelines for GMP and regulatory practices to ensure quality , safety and efficacy of medical devices… and participate in international harmonization”.

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4 | 3rd IMDRFmeeting, Nice | 20 March 2013

To promote improved access to safe and quality medical products

Medicines

Policies, access, pricing Essential Medical List (EML) Norms and standards ( INN) Regulation and safety monitoring Prequalification SSFFC medicines

Vaccines

Quality Safety Prequalification

Medical Devices

Policies for medical devices and HTA Health technology management Safe use Medical devices and IVD regulations Prequalification of IVD

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5 | 3rd IMDRFmeeting, Nice | 20 March 2013

Regulatory convergence in medicines and vaccines

 Nomenclature : INNs  WHO Expert Committees guidelines + norms/standards  ICH guidelines  ICDRA  (sub-)regional collaboration initiatives : EU, PANDRH, ASEAN; ARMH; APEC, …..  Global Safety Monitoring, Uppsala Center

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6 | 3rd IMDRFmeeting, Nice | 20 March 2013

To promote improved access to safe and quality medical products

Prequalification of priority diagnostics

Using GHTF guidance Inspection Laboratory evaluation Dossier review

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7 | 3rd IMDRFmeeting, Nice | 20 March 2013

Regulatory problems with prequalification of diagnostics

 Multiple regulatory versions for the "same" product  Variable stringency of regulatory review by NRAs

– depends on risk classification – if product is for export-only, minimal review

 Variable stringency of conformity assessment bodies/inspection agencies

– Some inspections may be outsourced to in-country agencies – Differences in QC lot release procedures for different regulatory agencies/ notified bodies

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8 | 3rd IMDRFmeeting, Nice | 20 March 2013

Strengthening Regulatory Capacity for prequalifing diagnostics

 Provide tailor-made technical support to Member States

– Legislative framework – Registration, processes and procedures, PMS

 Learning by doing

– Dossier assessments – Inspections – Lot testing

 Promote global harmonization (GHTF) and networking

– Fast track procedures – Sharing information

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9 | 3rd IMDRFmeeting, Nice | 20 March 2013

Regulations of medical devices

 In LMIC:

– lack of specialized knowledge, staff and resources to perform medical

devices regulations. – Very weak post market surveillance – Lack of regulation, identified as a barrier to safe and effective medical devices Only 65% of member states have any form of medical devices regulation Approximately only 33% have IVD regulation

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10 | 3rd IMDRFmeeting, Nice | 20 March 2013

Status of Nomenclature Systems in 144 MS

68 11 15 16 14 1 4 1 4 10 65

none

ther
nly UMDNS
nly GMDN
nly nationally developed

UMDNS + GMDN + nationally developed UMDNS + GMDN UMDNS + nationally developed GMDN + nationally developed no info

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11 | 3rd IMDRFmeeting, Nice | 20 March 2013

Importance of a nomenclature system

Nomenclature and product name

Transparent code designation for new / innovative products UDI manufacturer For regulatory authorities: registration, RSP, post market surveillance. In health services delivery, patients and health professionals: Access : from selection to safe use, tracking user problems

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Lack of regulatory convergence affects patients

 Hinders access to medical products  Increases final cost of medical devices  Slows access to innovative products  Decreases responsiveness to post-market problems  Increases possibilities of counterfeit devices  Quality and safety cannot be assured in an equitable manner.

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13 | 3rd IMDRFmeeting, Nice | 20 March 2013

WHO challenges and next steps: promote access to safe medical devices of good quality

– Need for global norms and standards for medical devices – Promote regulatory strengthening and convergence – Capacity building – Balance participation of LMIC in global regulatory process

f medical devices.

Safe use Regulatory

convergence R & D, production

Public health policies

Population health needs (MDGs, NCD)

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14 | 3rd IMDRFmeeting, Nice | 20 March 2013

Thanks medical devices/ en / www.who.int WHO Regions

Country Publications

WHO Medical Devices Reports (2008-2012)