Today ‘s age of AI has brought in tremendous success almost in every stream. Remarkably, AI has achieved tremendous success in the healthcare sector too. One such field of healthcare is regulatory intelligence where AI has proven its skills in achieving success of pharmaceutical products.
What Is Regulatory Intelligence?
Regulatory Intelligence (RI) is the new emerging part of regulatory affairs that overcomes the old traditional method of preparing and submitting regulatory documents. Regulatory Intelligence aims at keeping the company's leader updated with all the modifications and advancement in the field of regulatory affairs.
Importance Of Regulatory Intelligence:
Cost saving: RI emergence has made the regulatory process easy and therefore repeated actions and changes are not required in the documents, which eventually saves money.
Time saving: RI gives accurate and thorough information about any regulatory section thus saving the time of investigation for correct knowledge.
Systematic organization of regulatory document: Without much effort, RI systematically arranges the regulatory document as per the requirements.
Competitor tracker: It keeps track of the competitors that can decrease the value of our product and thus suggests the areas where improvements are required.
Regulatory changes update: RI is always updated with the recent advances of the regulatory bodies and any changes in the guidelines, thus eventually updating us.
Global compliance: RI helps in global product registration compliance.
Regulatory Intelligence In Successful Product Registration:
Regulatory Intelligence is the most powerful digital tool for successful product registration. Some of the key points are discussed below gives us an idea about the importance of regulatory intelligence in submissions:
Regulatory Intelligence leads to better understanding of the specific regulatory requirements and guidelines for the desired product to be registered.
It ensures that the product registration document meets the correct format requirement in terms of format, sequence and content.
It gives an understanding of the complaints the product registration may receive upon reviewing the final document, hence suggesting improvement for the same.
Regulatory Intelligence provides a platform for the manufacturer to discuss any doubts and queries about the product registration requirements with the regulatory authorities.
It helps in regulatory strategy for medical products registration.
Regulatory intelligence helps to speed up the process which would either required long time if done manually.
It helps in errorless processes and provides greater and quicker chances of approval.
It helps in the survival of global market competition.
The overall cost of the registration process is reduced as rework is not required.
Steps In The Process Of Product Registration Using RI:
The various steps in the product registration involves:
Recognize target market: Identification of the market where the drug is to be targeted is done in this step.
Understand the regulatory requirements: Understanding of the product regulatory requirements according to the country/region is done.
Prepare a registration plan: A plan for systematic registration is prepared.
Compilation of dossier registration: All the necessary documents are collected according to the requirements for the desired product registration.
Submission of registration application: After completion of all the above steps the registration application is submitted.
Observe the review process: After submission the review process is observed.
Meet the missed requirements, if any: If after the review process any amendments are required, they should be made and submitted to the regulatory authorities.
RI Challenges For Product Registration:
Continuous upgradation: The RI system needs to be continuously updated according to the new and changed guidelines for providing correct data.
Meeting all regional requirements: Every region has different guidelines according to their regulatory bodies, thus it's difficult for the RI to feed all the varying regulatory requirements according to different regions
Data relevancy filtering: As there is huge data daily encountered by the RI, it is time consuming and difficult for it to filter the data according to its relevancy.
Expensive RI system: However, as the cost of regulatory process may have reduced, the whole RI system is very expensive.
Competitor monitoring difficulties: As it is difficult to get insights into the competitor's procedures and strategies it sometimes becomes difficult for the RI to provide tips to overcome this competition.
Post approval changes focus: The RI model focuses mainly on the pre-approval part of the drug product whereas the post approval part should also be looked in for product betterment, which RI lacks.
Hence, we can conclude that Regulatory Intelligence (RI) plays a vital role in the field of product registration, ensuring that the product meets all the requirements and guidelines for the registration. It reduces the product risk factor and also reduces the chances of product registration rejection. It keeps the manufacturer updated about all the regulatory changes and the emergence of new guidelines. Thus, RI has proven to be a boon for successful product registration.
FAQs
Q: What is regulatory intelligence in product registration?
A: Regulatory intelligence is a digital healthcare tool which assists in product registration by providing all the required guidelines and procedures.
Q. What is the difference between regulatory intelligence and regulatory compliance?
A: Regulatory intelligence collects and analyzes regulatory data, while regulatory compliance ensures that the rules and guidelines are correctly followed.
Q. How is regulatory intelligence managed effectively by smaller companies?
A: Smaller companies usually take help from consultancy specialized in regulatory intelligence.
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