Comprehensive Overview of the Drug Development Process and Regulatory Framework

Comprehensive Overview of the Drug Development Process and Regulatory Framework

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  Overview of DrugDevelopment Process and Drug Development Teams Dr. Chinmaya Mahapatra
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  Learning Objectives At theend of this lecture, students should be able to: •Explain the complete drug development process. •Describe various stages of drug development. •Understand the timeline from drug discovery to market approval. •Discuss the regulatory framework governing drug approval. •Explain the role of multidisciplinary drug development teams. •Describe interactions among different functional departments during drug development.
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  Why Do WeNeed Drug Development? Medicines should be •Safe •Effective •High Quality •Stable •Affordable Drug development ensures that every medicine reaching patients has demonstrated •Quality •Safety •Efficacy before marketing approval. Key Message Patients receive only those medicines whose benefits outweigh their risks.
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  What is DrugDevelopment?
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  Drug Discovery vsDrug Development Drug Discovery v Drug Development Drug Discovery Drug Development Identify disease target Develop candidate medicine Screen compounds Conduct preclinical studies Optimize lead compound Manufacture clinical batches Laboratory research Clinical trials Select drug candidate Regulatory approval Discovery asks "What could work?" Development asks
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  Stages of DrugDevelopment 1. Discovery Identification of potential molecules 2. Preclinical Development Laboratory and animal studies 3. Clinical Development Human studies 4. Regulatory Review Evaluation by regulatory agencies 5. Post-Marketing Surveillance Continuous safety monitoring
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  Preclinical Development Objectives Evaluate •Pharmacology •Toxicology •Pharmacokinetics •Pharmacodynamics •Safety Studies performed •Acutetoxicity •Repeated dose toxicity •Genotoxicity •Carcinogenicity •Reproductive toxicity •Safety pharmacology Performed according to Good Laboratory Practice (GLP)
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  Investigational New Drug(IND) Before testing in humans Sponsor submits IND containing •Animal safety data •Manufacturing information •Clinical protocol •Investigator brochure Purpose Obtain permission to begin clinical trials.
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  Clinical Development Clinical trialsevaluate Safety Efficacy Dose Adverse reactions Benefit-risk profile Conducted according to Good Clinical Practice (GCP)
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  Clinical Trial Phases PhaseParticipants Purpose Phase I 20–100 Safety Phase II 100–300 Efficacy Phase III 1000–3000 Confirm efficacy Phase IV Large population Long-term safety
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  Why Does DrugDevelopment Take So Long? Reasons Rigorous testing Patient safety Regulatory compliance Manufacturing validation Clinical recruitment Data analysis Low success rate Only a very small fraction of screened compounds eventually become approved medicines.
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  Regulatory Framework Drug developmentis regulated to ensure Quality Safety Efficacy Consistency Compliance Major agencies monitor every stage.
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  Major Regulatory Authorities India •CDSCO •DCGI UnitedStates •US FDA Europe •EMA United Kingdom •MHRA Japan •PMDA Australia •TGA Global •WHO
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  International Council forHarmonisation (ICH) Purpose Harmonize technical requirements globally. Major members •FDA •EMA •Japan Benefits Common standards Reduced duplication Global submissions Improved quality
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  Important ICH Guidelines Quality(Q) Safety (S) Efficacy (E) Multidisciplinary (M) Examples Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality System E6 Good Clinical Practice M4 Common Technical Document
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  Challenges in Drug Development Highfailure rate Long timelines Huge investment Regulatory complexity Patient recruitment Data integrity Changing guidelines Market competition