Today, Regulatory Affairs is a dynamic business unit that works with a focus on bringing products with a commercially viable label to market in the least possible time and expense. In view of the increasing global competition among pharmaceutical companies, the key to success lies in obtaining timely marketing approval from the Regulatory Affairs of the region where the drug will be sold. Various government agencies are involved in regulating drugs within their market. Some of them include:
USFDA-US, EMEA-Europe, TGA-Australia and MHRA-UK and TPD-CANADA.
Patent expirations, tighter healthcare budgets and a stricter regulatory climate are the main challenges for the pharmaceutical industry. Many companies are in a race to place their new products on the world market to gain market share and increase profits.
In such a scenario, a small delay in gaining market access means a large loss in terms of market share and revenue generated. The keys to success for pharmaceutical companies lie in obtaining timely marketing approval from regulators. Therefore, to obtain timely marketing approval, companies can either strengthen their regulatory department or outsource it to a regulatory affairs consulting firm.
Current regulatory scenario
The main legislation governing clinical trials is the Drugs and Cosmetics Act, 1940 and the authority of the Directorate is the Controller General of Drugs of India (DCGI). Schedule Y of the Drugs and Cosmetics Rules, 1945 stipulates the regulations for importing and manufacturing new drugs for sale and for conducting clinical trials in India. In addition, the Indian Council of Medical Research (ICMR) has issued Ethical Guidelines for Biomedical Research in Human Participants and the Central Organization for Drug Standards Control has formulated Good Clinical Practice Guidelines (GCP Guidelines) in line with international guidelines issued by the World Health Organization and International Committee for Harmonization (ICHGCP), which provides operational guidelines for ethical and scientific standards for the design of a clinical trial protocol that includes conduct, registration, safety, and notification procedures. It is mandatory for all organizations conducting a clinical trial in India to strictly adhere to these guidelines.
There is no denying the fact that clinical trials are the foundation for introducing better drugs, medical practices, and devices. The fact that it involves law and ethics makes it a challenge for those who frame legal provisions. The Ministry of Health and DCGI must leave no room for complacency when it comes to human trials and ensure that gaps are filled by ensuring uniformity and unambiguity of existing regulations. However, the law has the power to regulate, control and guarantee the protection of subjects only to a limited extent.
With changing global regulatory standards, outsourcing regulatory affairs work seems like a more beneficial option both in terms of time and money. Maintaining a large regulatory affairs department can be very expensive and the scope of knowledge may be limited to certain aspects. On the other hand, a regulatory affairs consultant stays up to date with current regulation and has vital experience in the field to streamline the approval process.
Pharmaceutical regulatory affairs involves both generic and investigational new drugs (INDs). Well-established regulatory firms can provide services in the following ways:
Compilation and formulation of large regulatory requests for the presentation of both APIs in different countries, commonly called dossiers.
Experience in regulatory and scientific knowledge.
Specialized knowledge and support in terms of the local regulatory authority.
Expert solutions to inquiries from the FDA and other regulatory agencies. Access to scientific and technical resources.
Formulation and implementation of regulatory strategies at a global level.
The Regulatory Affairs unit in the Pharmaceutical industry acts as the backbone for its survival. It relates to the implications for public health, standard setting and intellectual property rights in drug development, the public accountability of regulatory agencies, the procedures used by pharmaceutical companies for regulatory compliance, and addresses the complex web regulatory requirements, application processes and quality control. Problems affecting the pharmaceutical industry.
On the other hand, a regulatory firm will expedite the filing process along with the active participation of the client (party that engages the regulatory firm). Once established, the service offered by the regulatory affairs professional can help the company save time and money. Hence the importance of an adequate selection of the regulatory professional. Consultants must have experience preparing and submitting regulatory documents and extensive knowledge of obtaining approval for various drugs, and be able to formulate and implement regulatory strategies. Professional references, papers prepared, endorsements obtained, and articles published by them may be better sources for evaluating their expertise.