REGULATORY AUTHORITIES

For every country, the health of its people is of utmost importance. To maintain the

health of the people country has to ensure the quality of medicines and other

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Summary

Summary 143

pharmaceutical products as well as devices. So, every country has its regulatory

authority which regulates the following:

1. Import of drugs from another country

2. Export of drugs to another country

3. Manufacturing of drugs in the country

4. Establishment of manufacturing companies in the country

5. Dispensing of medicines

6. Approval of new drugs

7. Approval for clinical trials

8. Testing of drugs in the certified laboratories

9. The compliance with international guidelines

10. Regular inspections

11. Issuing various types of licence related to drugs

ROLE OF REGULATORY AFFAIRS DEPARTMENT

Drug regulatory affairs is a dynamic and challenging field in the pharmaceutical

industry. It has to deal with government authority on one hand and applicant/company

on another hand. Because of the crucial nature of the job regulatory affairs professionals

should be experts in managing the product life cycle. They should have the capability

to solve technical as well as administrative problems within the limits of laws and

regulations. Regulatory affairs department is a bridge between government regulatory

authority and pharmaceutical company. It also has a connection with all the

departments of the company internally.

Regulatory affairs department plays many important roles. These are as follows:

• Role in drug development

• Role in drug approval

• Keep other departments updated

• Acts as interface

• Acts as an adviser

• Maintenance of licences

• Preparation of documents

• Helps in the execution of clinical plan

• Data collection and storing

RESPONSIBILITY OF REGULATORY AFFAIRS PROFESSIONALS

There are some qualities which make efficient regulatory professionals. These are:

• Good communication skills

• Good computer knowledge

• Work independently

• Active listeners

• Good presenter

• Good data management skills

• Patient worker

• Effective negotiator

• Punctual

• Have sound knowledge

144 Industrial Pharmacy

Because of the critical nature of this job, there are several important responsibilities

of regulatory affairs professionals. These are as