RoleofRegulatoryInformation ManagementSystems-RIMSToolsin
AsiaMarket
Managing regulatory information for a pharmaceutical product along all stages of its life cycle is a key challenge in the pharmaceutical industry. Now, as more opportunity markets emerge bringing their own stringent regulations and changes in previous regulations, managing regulatory information is becoming increasingly complex which can delay market access for products Furthermore, information is gathered in separate systems that canbedisconnectedfromeachotherwhichcanalsocause hurdles and prolong the product-to-market process Thus, Regulatory InformationManagementSystem (RIMS)toolsareneededtoconsolidate and integrate such information onto one system to enable a holistic and efficient approach to RIMS Tools, while maintaining regulatory compliance.
Benefits of Adopting Digitization in Regulatory Data Management
Adopting digitization to systematically manage regulatory data embracesadvancedanalyticstodoso.Thiswouldallowbetterdata to be recorded so that data could be monitored and shared in a moreefficientmannerwhichwouldsmoothenoperationalworkflow. Additionally, businesses would be able to extract necessary insight andapplythemforregulatorystrategydecision-making.
RIMS tools alsoincorporateautomationfortasksandprocessesthat are time-consuming and repetitive Automation technologies such as machine learning (ML) and process automation can enhance processessuchaseventcapturingandmanagingworkflow.
Transparency and Collaboration with Regulatory RIMS Tools
Fromabusinessperspective,RIMStoolsallowtransparencywhen conductingregulatoryfunctionsandinteractionsbetweeninternal and/orexternalcollaboration,beitothercontenders,stakeholders,or regulatorypartners.Asthetrendforoutsourcingregulatoryfunctions increases,theneedforsecure,cloud-basedplatformsthatexploit automationandtechnologyforefficientoperationsismorethan ever.Nodoubtthiswouldfacilitatebettercollaborationbetweenall relevantparties.
Scope for Pharma RIMS tools in Asia
ThepharmaceuticalmarketisrapidlygrowinginAsiaandproviding immenseopportunitiesforpharmaceuticaldevelopment.Already, AsiancountriessuchasChina,Japan,India,andKorearankamong thetop10economiesintheworld.
Thus,theAsianmarketisincreasinglybecomingattractivefor companiesaroundtheworldduetonotonlyitsstrongeconomies, butalsoitspopulationsize.
Needlesstosay,thereisapositivecorrelationbetweenpopulation sizeandhealthcareneeds–withmorepeoplecomesincreasing healthcareneeds
Furthermore,healthcareneedsincreaseincountrieswherethe ageingpopulationisrelativelyhigh,likeinJapan.
Regulatory Landscape in Asian Markets
Undoubtedly,itisimportanttobeawareofchangesinregulatory requirementsandtheoverallregulatorylandscape,tosuccessfully entertheAsianpharmaceuticalmarket.
Withpharmaceuticalproductregistrationregulationsbecoming morestringentandnewpoliciesbeingimplementedtosupportdrug innovation,internationalcompaniescouldfacechallengesin bringingtheirproductstothemarket
Opportunities for RegTech in Asia
Theriseinregulatorychangeswithinthismarkethasalsoprovideda platformofopportunitiesforexploitingregulatorytechnology-orReg Tech.AccordingtotheIrishAdvantageReport,thereasonbehindthe growthofRegTechisaresultof“rapiddevelopmentofemerging Asianmarketsandfinancialsystems,increasedinvestmentinnew technologiesanddigitaltransformation,greaterregulatory acceptance,andextensiveinfrastructuredevelopment”.
Potential of RIMS in Asian Markets
GiventhegrowingeconomyofAsiancountriessuchasJapan,Korea, Singaporeetc,theincreaseinpharmaceuticalproductneedtofulfill healthcarerequirementscoupledwithinvestmentsindigitizationand newtechnologies,providesanattractiveandopportunisticmarket forRIMsystemsparticularlyforachievingrapidmarketapprovalsas smoothlyandquicklyaspossible.
DDReg Pharma’s RIMS Regulatory Software – Vitalic
AtDDRegPharma,wehaveleveragedtechnologicalinnovationand ourregulatoryintelligencetoassistpharmaceuticalcompaniesin providingdynamicregulatorydatatoauthoritiesandvarious stakeholders.
OurRIMStoolmanagesregulatoryproductlifecycletoensure first-timerightfilingsforallproducts-beitgenericstobiosimilars-in regulatoryandemergingmarkets.
DDReghascreatedauniqueRIMSlandscape“Vitalic”toeasethe challengesfacedbytheindustry.ToknowmoreaboutourRIMS software,reachouttous–info@ddregpharmacom
