Need of Regulatory Affairs in Biotechnology

By: Shabeena Zaidi

What is Biotechnology ?

• Biotechnology : biology + technology

 

• A technique that can make or modify the products of living organisms to improve plants or animals, or to develop useful microorganisms.

 

• It uses cell and tissue culture, cell fusion, molecular biology, recombinant (DNA) technology to generate unique organisms with new traits or organisms that can produce specific products.

Uses of Biotechnology

• Production of Drugs and Therapeutics

 

• Genetically modified organisms

 

• Analysis of the Genes in genetic disease

 

• Correction of genetic defects.

Contribution to Human Health

‘New’ Biotechnology focused on the technologiesrequired to:

Clone . Over express. Purify and Administer biopharmaceuticals.

Like,• Insulin• Human growth hormone• Erythropoietin .• 200 other proteins in the pipeline.• Edible vaccines.• Interleukins and interferon's.

Contribution to the environment

• Helps in ‘clean’ manufacturing, chemical manufacturing, and petroleum refining industries generate hazardous wastes viz: petroleum hydrocarbons and heavy metals.

 

• Bioremediation helps in cleaning up hazardous sites by treatment of contaminated soil, groundwater, industrial wastewater marine oil spills.

 

• Contribution to global economy, by the introduction of recombinant DNA technology to the production of biopharmaceuticals.

Contribution to Pharmaceutical Industry

• Traditional pharmaceutical drugs are simple molecules found through trial and error to treat symptoms of disease . They are manufactured by chemistry.

 

• Biopharmaceuticals are larger molecules created by living cells in human body.

 

• They can deal with targets in humans that may not be accessible with traditional medicines.

 

Contribution to Pharmaceutical Industry: Cont..

• Biotechnology has made landmark breakthroughs in new medical therapies to treat  

– Hepatitis B and Hepatitis C – Cancers, and Arthritis – Heamophilia,and Bone Fractures– Multiple sclerosis and Cardiovascular disorders.

•  Easy and cheap production of human growth hormone and clotting factors for:

– Haemophiliacs– Fertility drugs– Erythropoietin

What is Regulatory Affairs ?

A new profession developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in :-

• Pharmaceuticals• Veterinary medicines• Medical devices, pesticides• Agrochemicals, cosmetics and complementary medicines

The Regulatory Affairs Dept. takes part in development of product marketing concepts and required to approve packaging and advertising before it is used commercially.

Functioning roles of R.A dept:

The Regulatory Affairs professionals keep track of the

changing legislation in the regions in which the company distributes its products.

They advise on :

– Legal and scientific restraints and requirements,– Collect, collate, and

– Evaluate the scientific data that their R&D Dept.

generates.

Functioning roles of R.A dept. Cont...

• Present registration documents to regulatory agencies, and carry out negotiations necessary to obtain marketing authorisation for products.

• Give strategic and technical advice in their companies, right from the beginning of the development of a product,

• Their RA dept must be aware of the regulatory requirements in all the company’s export markets.

Functioning roles of R.A dept. Cont...

They are link b/w the company and worldwide regulatory agencies such as:

• USFDA1 (United States Food and Drug administration)

• European Union of Drug Regulatory Affairs (EUDRA).

Need of R.A in Biotechnology

• New Biotech medicines are coming up for cure of HIV, muscular degeneration, prostate cancer, asthma etc. so registration of new drug is required before marketing licence is granted, for success in biotech sector.

• Biotech firms employ QA associates to review good manufacturing practices (GMP) documents. GMPs are legal regulations by the FDA to ensure effectiveness of drug products.

Need of R.A in Biotechnology Cont..

• High cost and risks associated with the R&D of new bioengineered products demand realistic legislative policy at national and international levels.

• Since patents and regulation (e.g. FDA in U.S.) are very important issues for biotech enterprises, bioengineers are required to deal with management, economic and legal issues.

 

Need of R.A in Biotechnology Cont..

• For vaccines, allergenic, cell and tissue-based products, and biotech products, new biologics are required to go through a pre-market approval process..

 

• The original authority for government regulation of biological products was established by the 1902 Biologics Control Act.

Industry skills and needs in Biotechnology

Why is Regulatory Affairs important?

• Reduction of the time taken to reach market is critical to product’s and the company’s success ensured by R.A.

• Inadequate reporting of data or release of product with incorrect labelling, may result in loss of several millions sales unit, reduction in confidence of the investors, patients.

• A good Regulatory Affairs professional will help to maximise the cost-effective use of the company’s resources.

• This Dept. is first point of contact between the government authorities and the company. Officials respond better to a company whose representatives are scientifically accurate and knowledgeable.

What makes a good Regulatory Affairs Professional?

• Most regulatory professionals are graduates in a scientific discipline – commonly life sciences or pharmacy – although increasingly biotechnology-based degrees are valuable.

• The ability to tackle data in a wide range of scientific areas and to quickly grasp new concepts and complex technical information is vital.

• Regulatory professionals must always consider judgement in the practice. Integrity and the ability to inspire trust and confidence are valuable attributes.

What makes a good Regulatory Affairs Professional? Cont...

• Communication skills are very important.

• An analytical frame of mind is important. An ability to evaluate the strengths and weaknesses of the technical and legal options for a company.

• Project management skills help to achieve the challenging goals. They can work in multi-disciplinary teams and can work under pressure and inspire others.