4.2 TT-Approved regulatory bodies and agencies.pdf

Technology development and transfer: Approved regulatory bodies and agencies

1. Technology development and transfer:
Approved regulatory bodies and agencies
Dr. Kumara Swamy Samanthula
M. Pharm, Ph.D
Associate Professor
Faculty of Pharmaceutical Science
ASSAM DOWN TOWN UNIVERSITY

2. Introduction
•Asthepharmaceuticalindustriesthroughouttheworldaremovingahead
towardsbecomingmoreandmorecompetitive,regulatoryagenciesare
beingestablishedinvariouscountriesacrosstheglobe.
•Regulatoryauthorityandorganizationsareresponsibleineffectivedrug
regulationrequiredtoensurethesafety,efficacyandqualityofdrugs,as
wellastheaccuracyandappropriatenessofthedruginformationavailable
tothepublic.
•Regulatorybodiesprovidestrategic,tacticalandoperationaldirectionand
supportforworkingwithinregulationstoexpeditethedevelopmentand
deliveryofsafeandeffectivehealthcareproductstoindividualsaroundthe
world.
•Objective
•Safety&Quality
•Effectiveness

3. Drug Development Process and Regulatory Role
•Newdrugsbegininthelaboratorywithscientists,includingchemistsand
pharmacologists,whoidentifycellularandgeneticfactorsthatplayarolein
specificdiseases.
•Theysearchforchemicalandbiologicalsubstancesthattargetthesebiological
markersandarelikelytohavedrug-likeeffects.
•Outofevery5,000newcompoundsidentifiedduringthediscoveryprocess,
approximatelyfiveareconsideredsafefortestinginhumanvolunteersafter
preclinicalevaluations.
•Afterthreetosixyearsoffurtherclinicaltestinginpatients,onlyoneofthese
compoundsonaverageisultimatelyapprovedasamarketeddrugfor
treatment.

4. Country Name ofRegulatory Authority
USA Food and Drug Administration (FDA)
UK Medicines and Healthcare Products
Regulatory Agency (MHRA)
Australia Therapeutic Goods Administration (TGA)
India Central Drug Standard Control Organization
(CDSCO)
Canada Health Canada
Europe European Medicines Evaluation Agency
(EMEA)
Denmark Danish Medicines Agency
Costa Rica Ministry of Health
New Zealand Medsafe-Medicines and Medical Devices
Safety Authority
Major Regulatory Agencies World Wide

5. Country Name ofRegulatory Authority
Sweden Medical Products Agency (MPA)
Netherlands Medicines Evaluation Board
Ireland Irish Medicines Board
Italy Italian Pharmaceutical Agency
Nigeria National Agency for Food and Drug
Administration and Control (NAFDAC)
Ukraine Ministry of Health
Singapore Centre for Pharmaceutical Administration
Health Sciences Authority
Hong Kong Department of Health: Pharmaceutical
Services
Paraguay Ministry of Health
Sweden Medical Products Agency (MPA)

6. Country Name ofRegulatory Authority
Thailand Ministry of Public Health
China State Food and Drug Administration
Germany Federal Institute for Drugs andMedical Devices
Malaysia National Pharmaceutical Control Bureau,Ministry
of Health
Pakistan Drugs Control Organization, Ministry of Health
South Africa Medicines Control Council
Sri Lanka SPC,Ministry of Health
Switzerland Swissmedic, Swiss Agency for Therapeutic
Products
Uganda Uganda National Council for Science and
Technology (UNCST)
Brazil Agencia Nacional de Vigiloncia Sanitaria (ANVISA )
Japan Ministry of Health, Labour& Welfare(MHLW)

7. INTERNATIONAL ORGANIZATIONS
World Health Organization (WHO)
Pan American Health Organization (PAHO)
World Trade Organization (WTO)
International Conference on Harmonization (ICH)
World Intellectual Property Organization (WIPO)

8. Functions of Regulatory Agencies
•Productregistration,drugevaluationandauthorization,and
monitoringofdrugefficacyandsafety.
•Regulationofdrugmanufacturingimportanceanddistribution.
•Regulationandcontrolofdrugpromotionandinformation.
•Adversedrugreaction(ADR)monitoring.
•Licensingofpremises,personandpractices.
•Maingoalofdrugregulationistoguaranteethesafety,efficacy
andqualityofdrugs.

9. Clinical Investigation
•US:
•IND –Investigational New Drug (Application)
•IND --isa drug or biological drug that has not been approved for general use by the FDA.
•EU:
•CTA / CTX –Clinical Trial Authorization/Clinical Trials Exemption

10. Marketing Approval
•US:
•NDA –New Drug Application ,(An application submitted by the manufacturer of a
drug to the FDA -after clinical trials have been completed -for a license to market the
drug for a specified.)
•ANDA -Abbreviated New Drug Application, (contains data which is submitted to
FDA for the review and potential approval of a generic drug product.)
•BLA –Biologic License Application
•EU:
•MAA –Marketing Authorization Application
•CTD–Common Technical Document, Common format for marketing
authorization (registration)

11. Labelling
•US: Primary and Secondary Container, Package Insert (PI),
Patient Package Insert (PPI), Structured Product Labeling (SPL)
•EU: Summary of Product Characteristics (SPC), European Public
Assessment Report (EPAR)

12. LABELLINGREQUIREMENTS
1)Commonorgenericnameof theproduct.
2)Product function
3)Useinstruction
4)Name&addressof Manufacturer
5)Countryofmanufacture
6)ManufactureDate
7)Expirydate
8)NetQuantity
9)RetailSale Price
10)Storagecondition
11)Barcodes
12)Batchnumber
13)WarningorCautionifhazardexists
14)ManufacturingLicenseNumber
15)Ingredients
16)RegistrationCertificateNumber(RCN)
17)ConsumerCareDetails
18)UsingStickers
19)Brown/Redorgreendot
20)‘NotastandardpacksizeunderLegal
Metrology(Packaged commodities)Rules,
2011’

13. Challenges
The major challenges of these regulatory bodies are
To promote public health and protect the public from harmful and dubious
drugs,
To establish proper legalization covering all products with a medicinal claim
and all relevant pharmaceutical activities, whether carried out by the public
or the private sector.
To increase worldwide regulatory growthto ensure safety of people.

14. Why we need it?
•1. More centralized procedures in drug regulation
•2. Harmonization of regulatory norms
•3. Strengthening the regulatory authorities

15. Medical Regulatory Structure in India
•MINISTRY OF HEALTH AND FAMILY WELFARE
•NATIONAL DRUG AUTHORITY STATE LEVEL AUTHORITY
•CDSCO NEW DELHI State F and D administration for each state and territories

16. CDSCO
•TheCentralDrugsStandardControlOrganisation(CDSCO)underDirectorateGeneralofHealth
Services,MinistryofHealth&FamilyWelfare,GovernmentofIndiaistheNationalRegulatory
Authority(NRA)ofIndia.ItsheadquarterislocatedatFDABhawan,KotlaRoad,NewDelhi110002
andalsohassixzonaloffices,foursubzonaloffices,thirteenPortofficesandsevenlaboratories
spreadacrossthecountry.
•TheDrugs&CosmeticsAct,1940andrules1945haveentrustedvariousresponsibilitiestocentral
&stateregulatorsforregulationofdrugs&cosmetics.Itenvisagesuniformimplementationofthe
provisionsoftheAct&Rulesmadethereunderforensuringthesafety,rightsandwellbeingofthe
patientsbyregulatingthedrugsandcosmetics.CDSCOisconstantlythrivingupontobringout
transparency,accountabilityanduniformityinitsservicesinordertoensuresafety,efficacyand
qualityofthemedicalproductmanufactured,importedanddistributedinthecountry.
•UndertheDrugsandCosmeticsAct,CDSCOisresponsibleforapprovalofDrugs,Conductof
ClinicalTrials,layingdownthestandardsforDrugs,controloverthequalityofimportedDrugsin
thecountryandcoordinationoftheactivitiesofStateDrugControlOrganizationsbyproviding
expertadvicewithaviewofbringabouttheuniformityintheenforcementoftheDrugsand
CosmeticsAct.
•FurtherCDSCOalongwithstateregulators,isjointlyresponsibleforgrantoflicensesofcertain
specializedcategoriesofcriticalDrugssuchasbloodandbloodproducts,I.V.Fluids,Vaccineand
Sera.

17. Central Drug Testing Laboratories
•1.CentralDrugsLaboratory(CDL)Kolkata
•I.StatutoryFunctions:
•AnalyticalqualitycontrolofmajorityoftheimportedDrugavailableinIndianmarket.
•AnalyticalqualitycontrolofdrugandcosmeticsmanufacturedwithinthecountryonbehalfoftheCentralandState
DrugControllerAdministrations.
•ActingasanAppellateauthorityinmattersofdisputesrelatingtoqualityofDrug.
•II.OtherFunctions:
•Collection,storageanddistributionofInternationalStandardInternationalReferencePreparationsofDrugand
PharmaceuticalSubstances.
•PreparationofNationalReferenceStandardsandmaintenanceofsuchStandards.Maintenanceofmicrobialcultures
usefulindruganalysisDistributionofStandardsandculturestoStateQualityControlLaboratoriesanddrug
manufacturingestablishments.
•TrainingofDrugAnalystsdeputedbyStateDrugControlLaboratoriesandotherInstitutions.
•TrainingofWorldHealthOrganizationFellowsfromabroadonmodernmethodsofDrugAnalysis.
•ToadvisetheCentralDrugControlAdministrationinrespectofqualityandtoxicityofdrugawaitinglicense.
•ToworkoutanalyticalspecificationsforpreparationofMonographsfortheIndianPharmacopoeiaandthe
HomoeopathicPharmacopoeiaofIndia.
•ToundertakeanalyticalresearchonstandardisationandmethodologyofDrugandcosmetics.
•AnalysisofCosmeticsreceivedassurveysamplesfromCentralDrugStandardControlOrganization.
•QuickanalysisoflifesavingDrugonanAll-IndiabasisreceivedunderNationalSurveyofQualityofEssentialDrug
ProgrammefromZonalOfficesofCentralDrugStandardControlOrganization.

18. Central Drug Testing Laboratories…
•2. Central Drugs Testing Laboratory (CDTL) Chennai , Tamil Nadu
•3. CENTRAL DRUGS TESTING LABORATORY HYDERABAD
•4. Central Drugs Testing Laboratory (CDTL) Mumbai
•5. Regional Drugs Testing Laboratory (RDTL) Guwahati
•6. Regional Drugs Testing Laboratory (RDTL) Chandigarh
•7. Central Drugs Laboratory, CDL Kasauli, Himachal Pradesh

19. CDSCO
MISSION
To safeguard and enhance
the public health
by assuring
the safety, efficacy and quality
of
drugs, cosmetics and medical devices
Central Drugs Laboratory (CDL) Kolkata