Role in drug approval: A dossier is to be submitted to the competent authority for

drug approval. This dossier is prepared by regulatory affairs department in compliance

with the respective guidelines. Each aspect of the dossier/application is taken care by

the regulatory affairs department and all the queries from competent authorities

regarding the application are also answered by the regulatory affairs department.

Keep other departments updated: It is regulatory affairs department which keeps

other departments such as production, marketing, quality control, pharmacological,

etc updated with recent rules and norms to be followed during developmental stages.

This helps in ensuring quality and safety of drugs.

Acts as interface: It is the most critical role played by the regulatory department.

The department acts as an interface between health agencies and the company. It also

acts as a link between different departments of the company.

Acts as an adviser: During the lifecycle of a drug there are several occasions when

it becomes difficult for the company to take the decision. Regulatory affairs department

acts as an advisor and gives strategic advice which helps in taking extreme difficult

decisions.

Maintenance of licences: Regulatory affairs department keeps track on when a

licence is going to expire and file the renewal within appropriate time to avoid the loss

of the company. The department also ensures availability and maintenance of the

marketing licence. Any change in the formulation, labelling, manufacturing site, etc is

informed by the regulatory department to the health agencies.

Preparation of documents: Regulatory affairs department helps other departments

in preparing the company related documents as per rules and guidelines. For example,

Standard Operating Procedure (SOP), Batch Process Control Record (BPCR), Master

Formula Record (MFR), Certificate of Analysis (CoA), CTD, etc.

Helps in the execution of clinical plan: Clinical studies are very important part

when it comes to the market approval of new drugs. The clinical plan should be in

accordance with GCP and drug should be approved for clinical investigation. Much

other legal documentation is also required like investigators brochure, informed consent

Fig. 7.3: The regulatory professionals act as bridge between company and government drug regulatory

authority

Regulatory Affairs and its Role 119

form, clinical study protocol, etc. Regulatory affairs department helps the company in

execution of the clinical plan by assisting in preparing the documents in compliance

with guidelines and filing the application for clinical trials approvals. This is same in

the case of execution of non-clinical plan as well.

Data collection and storing: All the data from the drug development stage to postmarket approval phase is collected and stored by the regulatory affairs department.

The data from the drug development stage is collected to use in licensing application.

The data stored for future reference and the renewal of licence.