Challenges in regulating Radiopharmaceuticals: view of the

International Consultancy Group affiliated to IAE

13TH INTERNATIONAL CONFERENCE OF DRUG REGULATORY AUTHORITIES( ICDRA ) Bern, Switzerland16th – 19th September 2008

Kadariah Mohd. AliPharmacy Practices & Development Division, Ministry of Health, Malaysia

Ministry of Health, Malaysia

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Meeting on Pre-qualification of Radiopharmaceuticals26-29 May 2008 Division of Human HealthInternational Atomic Energy Agency, Vienna, Austria

• Orhan H Suleiman - US FDA

• Jianguo Zhong -National Control Bureau for Pharmaceuticals & Biological, China

• Henry Leng -Representing MCC, South Africa

• Bente Pedersen -Danish Medicines Agency representing the EMEA

• Kadariah Mohd. Ali -Pharmaceutical Services Div., MOH, Malaysia

• Milan Smid – WHO

• Kishor Solanki – IAEA

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CancerClinical audits

Infectioncancerheart

Nutrition

PreventionQualityAssurance

Therapy Diagnosis

Major activities of IAEA in human health

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Meeting - Objectives

• To provide recommendations important from point of view of protection of public health

• To improve access to patients of radiolabelledproducts that are safe, effective, and of acceptable quality.

• To recommend a regulatory approach especially to those with regulatory inconsistencies and/or having limited regulatory resources.

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Regulatory inconsistencies

• Radiopharmaceuticals and their production facilities may comply with requirements for Radiation Safety

• However, not always compliant with respect to regulations governing Medicinal Risks, including Good Manufacturing Practice (GMP) requirements

• Primarily due to historic reasons

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Radiopharmaceutical Producers

Current GMP requirements applied to theindustrial production of pharmaceuticals maynot be followed by

• national laboratories • cyclotron PET facilities • hospital hot laboratories

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Regulatory Challenges

• DRA do have legal framework but inconsistencies include no assessment of Safety, Efficacy and Quality required for RP

• Without a doubt, overuse of exemption systems undermines legislative support, increase risk

• Significantly regulatory inconsistencies in some MS in exporting RP

• Industry is not interested to register RP because of lack of economically viable market.

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Principle position of working group

• Radiolabelled products for human use are drugs and should be regulated.

• Radiolabelled products have unique features e.g., specialized production methods, QC, dosing, radioactivity

• To achieve effective regulation co-operation between state authorities

• Without legislative support formal government healthcare reimbursement is difficult.

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Recommendations to Member States

1. Review current practices:

• Exemption mechanisms related to RP should not be overused

• Determine capacity to assess RP (including evaluators, analysts and GMP inspectors)

• If capacity is limited, simplifies documentation requirements and introduce fast tracking approval

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A close co-operation should be established between national authorities who inspecting the same manufacturers for radiation safety and for safety of medicines

2. Streamlined public safety efforts both from radiation safety and medicine inspections should be established

Recommendations to Member States

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Recommendations to WHO / IAEA

• Encourage better regulatory oversight among MS

• Establish an international common platform for harmonised product dossiers (CTD format) which would ‘Pre-Qualify RP)

Detailed mechanism will be established

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Module 1Regional

Administrative Information

NonclinicalOverviewQuality

OverallSummary Clinical

Summary

Module 3Quality

Module 4Nonclinical

Study Reports

Module 5Clinical

Study Reports

ClinicalOverview

NonclinicalSummaries

Not Part of CTD

CTD

.

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Model “Prequalification” Scheme -Objective

• To ensure quality, safety and efficacy of radiopharmaceutical medicines in international commerce,

• To improve access to patients ofradiolabelled products especially in regulatory resource-constrained country markets.

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Model “Prequalification” Scheme -Components• Evaluation of quality, safety and efficacy of RP medicines, inspections

of manufacturers and monitoring of the products after their prequalification.

• Prequalification of quality control laboratories for RP products.

• Building capacity of regulators, manufacturers and RP quality control laboratories.

• Establishing information platform (a website and an electronic database) to list pre-qualified RP, for RP product assessment and site inspection reports, which can be accessed by DRA and manufacturers.

• Information relevant for all stakeholders of the programme will be shared by this medium, including pharmacovigilance, urgent information in case of need.

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Conclusion

• International system of Pre-qualification which is transparent is essential

• Streamlined registration and licensing for Quality, safety and efficacy of RP used in clinical practice

• A close co-operation should be established between national authorities who are inspecting the same manufacturers for radiation safety and for safety of medicines.

Thank you for your attention

Kadariah Mohd. AliQuality & Standard UnitPharmacy Practices & Development Div.

Ministry of Health, Malaysia