Regulatory affairs

Short discussion about Regulatory affairs (RA) by Dipak Bhingardeve

1. Mr. DipakB. Bhingardeve
Assistant Professor
Department of Pharmaceutics

2. RegulatoryAffairs(RA)isaprofessionwithinthe
healthcareindustrynamely,Pharmaceutical,Medical
Device,Biologics,&FunctionalFood.
RegulatoryAffairsisaprofessionwhichhasdeveloped
fromthedesireofgovernmentstoprotectpublic
health,bycontrollingthesafetyandefficacyof
productsinareasincludingpharmaceuticals,
veterinarymedicines,medicaldevices,pesticides,
agrochemicals,cosmeticsandcomplementary
medicines.

3. RAprofessionatitsheartisallaboutCollecting,
AnalyzingandCommunicatingtheRisksandBenefitsof
healthcareproductstoregulatoryagenciesandpublic
allovertheworld.
RegulatoryAffairs(RA),alsocalledGovernment
Affairs,isaprofessionwithinregulatedindustries,such
aspharmaceuticals,medicaldevicesetc.
Thisdepartmentisresponsibleforunderstandingthe
regulatoryrequirementsforgettingnew/Generic
productsapproved.

4. Theyknowthecommitmentsthatcompanyhasmade
totheregulatoryagencieswheretheproductgoingto
beapproved.Theyalsosubmitannualreportsand
supplementstotheagencies.
DrugRegulatoryAffairsisafunctionwhichregulates
thepharmaceuticalscienceinordertofacilitate
trade/businessinandoutsidethecountryoforigin
forpublicinterest.

6. During1950’s,manytragedieshappenedduetothe
misjudgementofthepersonnelduringmanufacture
andsomeintentionaladditionofadulterationof
substancesintothepharmaceuticalproductwhichhas
leadtothedeathofthepatients.
Aftersomanyincidents,theregulatorybodies
introducedthenewlawsandguidelineswhichimprove
thequality,safetyandefficacyoftheproducts

7. Duetorapidincreaseinlaws,regulationsandguidelines
forreportingsafety,efficacyandqualityofnew
medicinalproducts,necessityforexpertregulatory
professionalarisestremendously.
Noneofthedrugmanufacturing/marketingunitsare
abletolaunchdruginmarketuntilandunless
respectivehealthauthority(national/international)
givegreensignalinwriting.
Withoutfulfillingrequirementsoflawofland,itis
practicallyimpossibletohavedrugproductsinmarket.

8. Almost two decades before, drug regulatory affairs was
least known / needed by pharmaceutical industry.
It was in very nascent stage where registration
executives were working under export department.
However,thesituationhaschangeddrasticallywhere
fullyfledgedGlobalRegulatoryAffairsdepartment
becomemandatorytodefinedrugdevelopment,
approvalandmarketingstrategy.
Hence,thescopeofDrugregulatoryaffairshas
becomevastandexpertsareneededinhealth
authoritiesandpharmaceuticalindustryatvarious
levelsanddepartments.

9. Atthesametime,theregulationpertainingto
pharmacovigilance requirements mandates
companiestomonitornewdrugssafetyaspects
throughoutthelifecycleofproduct.
Inthisscenario,theroleofregulatoryexpertisvery
criticalandimportantfordecidingtheentrystrategy
intovariousnationalandinternationalmarkets.

10. 1. Ensuring that their companies comply with all of the
system policy and laws pertaining to their business.
2.Workingwithfederal,state,andlocalregulatory
agenciesandworkingwithagenciesastheFoodand
DrugAdministrationorEuropeanMedicinesAgency
(pharmaceuticalsandmedicaldevices).
3.Advisingtheircompaniesontheregulatoryaspects
andclimatethatwouldaffectproposedactions.i.e.
describingthe"regulatoryclimate“intheregionof
issuessuchastheendorsementofprescriptiondrugs.

11. EvaluationofMarketingAuthorizationApplication
i.e.NewDrugsApplication,NewBiologicsApplication,
MedicalDeviceandCosmeticsapplication,Generic
Application,ClinicalTrialApplication,Variation
Application,DrugMasterFilesforAPI,Excipientsand
PackagingMaterials,SiteMasterFileforGMPinspection.

13. Support to Pharmaceutical Manufacturers:
1.SupportingManufacturerindefiningdrug
developmentpathwayduringPre-NDAmeetingand
providingcomments/confirmingdevelopmentpathway.
2.Timetotimemeetingwithpharmaceutical
manufacturersassociationtodiscussongoing
challenges,technicalissues,guidelines/guidance
documentsdiscussionandfuturedevelopment

14. Monitoring of Drug Safety and Efficacy:
1. Monitoring Drug Safety by collecting
Pharmacovigilance data and reviewing drugs in markets
time to time by reviewing labels and taking appropriate
action accordingly.
2. Monitoring Clinical Trials as well as approving study
results for next phase of study .

15. Regulatory systems and processes:
1. Keeping records for Drug Product Submission and
Approval database
2. Preparing Standard Operating Procedure (SOP) for
efficient management of drug regulatory affairs
department
3. Be part of Regulatory forums/ conferences/
webinars / seminars to exchange regulatory knowledge

16. TheRApersonneldevelopsstrategiestoovercome
delaysandpresentsfindingofclinicaltrialstothe
regulatorybodiessoastogetquickclearancethus
reducingthetimeforapprovalofnewmolecules.
Atitscore,theRAprofessionalfacilitatesthe
collection,analysisandcommunicationabouttherisks
andbenefitsofhealthproductstotheregulatory
agencies,medicalandhealthsystemsandthepublic.

17. The regulatory affairs personnel work hand in hand with
marketing and R&D to develop, innovative products
that take advantage of new technological and
regulatory developments to accelerate time to market.
With new products expected to add significant revenues
to the company’s bottom lines, small decreases in time
to market equate to large material gains in revenue and
profit.
Employing adaptive clinical trial strategies, obtaining
quick approval from regulatory authorities and avoiding
pitfalls in processes can accelerate development of new
products and help to reduce costly errors and time lags.

18. RegulatorybodiessuchastheFoodandDrugs
Administration(FDA)intheUSAareresponsiblefor
approvingwhetheradrugcanproceedtoclinicaltrials
andwhetheritshouldbeallowedtocomeintothe
marketornot.
Thesebodyhastoevaluatethescientificandclinical
datatoensurethatthedrugcanbeproducedwith
consistentlyhighpurity,bettertherapeuticresultsand
itdoesnothaveunacceptedsideeffects.

Itmustalsoapprovethelabelingofthedrugandthe
directionsforitsuseorwecansayregulatorybodyhas
takeninterestedinallaspectsofadrugdesigningand
itsformulatation.

19. Country Regulatory Body
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 EuropeanMedicines Agency(EMEA)
Japan Ministry of Health, Labour&
Welfare(MHLW)

20. 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 growth to ensure
safety of people.

21. Conclusion:
Regulatoryagenciesandorganizationsaroundtheworld
needtoensurethesafety,qualityandefficacyof
medicinesandmedicaldevices,harmonizationoflegal
proceduresrelatedtodrugdevelopment,monitoring
andensuringcompliancewithstatutoryobligations.
Howevertheneedofthehouris
*More centralized procedures in drug regulation
* Harmonization of regulatory norms
*Strengthening the regulatory authorities

22. Thedrugregulatoryaffairs(DRA)professionalplaysan
importantroleineveryphaseofthisprocess,from
developingregulatorystrategiesfollowingthediscovery
ofanewchemicalentitytoplanningpost-marketing
activities.
ThemainresponsibilityoftheDRAprofessionalwithina
pharmaceuticalcompanyistosecureapprovalofdrug
submissionsfromHealthTherapeuticProductsProgram
(TPP)andtoensureregulatorycomplianceofmarketed
andinvestigationaldrugswiththeFoodandDrugAct
andRegulationsandTPPGuidelines/Policies.

23. Inthisposition,theDRAprofessionalmustpossessa
proficientscientificbackground(B.Sc,M.Sc.,Ph.D.,
M.D.B.Pharm,M.PharmorPharm.D.)andhave
acquiredathoroughknowledgeofIndianregulationsas
wellasinternationalregulations.
Theyareresponsibleforthepresentationof
registrationdocumentstoregulatoryagencies,and
carryoutallthesubsequentnegotiationsnecessaryto
obtainandmaintainmarketingauthorizationforthe
productsconcerned.Theygivestrategicandtechnical
adviceatthehighestlevelintheircompanies.

24. Rightfromthebeginningofthedevelopmentofa
product,makinganimportantcontributionboth
commerciallyandscientificallytothesuccessofa
developmentprogramandthecompanyasawhole.
Italsohelpsthecompanytoavoidproblemscausedby
badlykeptrecords,inappropriatescientificthinking
orpoorpresentationofdata.

25. India is growing very rapidly in pharmaceutical sector;
there is a need of regulatory affairs professionals to
cater the current needs of industries for the global
competition.
Regulatory affairs professionals are the link between
pharmaceutical industries and worldwide regulatory
agencies.

26. Theyarerequiredtobewellversedinthelaws,
regulations,guidelinesandguidanceoftheregulatory
agencies.
Thereisagrowingneedtoincorporatethecurrent
requirementsofpharmaceuticalindustriesinthe
standardcurriculumofpharmacycollegestoprepare
thestudentswiththelatestdevelopmentstoserve
theindustries.