What is Regulatory Affairs ? - Useful content "D"

What is Regulatory Affairs?

Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.

Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals – and those who don’t rely on the expert advice of independent regulatory consultants to meet their obligations.

The Regulatory Affairs professional

The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products.They also advise on the legal and scientific restraints and requirements, and collect, collate and evaluate the scientific data their research and development colleagues are generating.

They are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned.

They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.

It may take anything up to 15 years to develop and launch a new pharmaceutical product and many problems may arise in the process of scientific development and because of a changing regulatory environment. Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising.

The Regulatory Affairs department will take part in the development of the product marketing concepts and is usually required to approve packaging and advertising before it is used commercially. Many companies operating in the high-technology healthcare and related industries operate on a multinational basis and are significant exporters.Their Regulatory Affairs departments must be aware of the regulatory requirements in all the company’s export markets.

As an added complication, despite recent international efforts towards harmonisation of requirements, the regulations laid down by different governments and their interpretation by the regulatory agencies rarely match. Consequently, the registration data prepared for one country frequently fail to meet the requirements for another.Therefore great care has to be taken in drawing up efficient and economical research and development programmes whose results may be used as widely as possible. Regulatory Affairs professionals, with their detailed knowledge of the regulations and guidelines, are frequently called in to advise on such matters.

Why is Regulatory Affairs important?

In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success.The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company.

Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost many millions of pounds, Euros or dollars to develop and even a three-month delay in bringing it to the market has considerable financial considerations. Even worse, failures to fully report all the available data, or the release of product bearing incorrect labelling, may easily result in the need for a product recall. Either occurrence may lead to the loss of several millions of units of sales, not to mention the resulting reduction in confidence of the investors, health professionals and patients.

A good Regulatory Affairs professional will have a ‘right first time’ approach and will play a very important part in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximise the cost-effective use of the company’s resources.

The Regulatory Affairs department is often the first point of contact between the government authorities and the company. The attitudes and actions of the Regulatory Affairs professionals will condition the perceptions of the government officials to the company - for better, or for worse! Officials respond much better to a company whose representatives are scientifically accurate and knowledgeable than to one in which these qualities are absent.

The importance of the Regulatory Affairs function is such that senior Regulatory Affairs professionals are increasingly being appointed to boardroom positions, where they can advise upon and further influence the strategic decisions of their companies.

How do Regulatory Affairs professionals relate to other professionals?

The very nature of the task brings regulatory personnel into contact with almost every discipline within the industry: pharmacologists, toxicologists, analytical chemists, pharmacists, medical doctors, veterinarians, engineers, physical chemists and statisticians.

That being said, the work is by no means confined to science but extends to the interface with and appreciation of advertising, marketing, legal, patent and manufacturing skills.

An ability to liaise closely with every kind of specialist is a crucial part of the job. Not only must there be the ability to use and assimilate information provided by such specialists, but also to present that information to regulatory authorities and feed back their opinions to the rest of the company and appraise staff about the current thinking of the regulatory bodies.

In short, the regulatory specialist is central to the business and has the opportunity to interact with a wide range of specialities and extend his or her knowledge while doing so.

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. Some choose to have an additional legal qualification, and TOPRA offers an MSc in Regulatory Affairs for those who wish to gain a formal professional qualification in the discipline.The ability to tackle data in a wide range of scientific areas and to quickly grasp new concepts and complex technical information is vital.

Communication skills are very important. Analysing issues and presenting both written and oral evidence before a panel of experts such as scientists, pharmacists, doctors and lawyers who run the government agencies requires considerable understanding of both legal and scientific matters. Attention to detail is a pre-requisite.

An analytical frame of mind is important, too. An ability to evaluate the strengths and weaknesses of the technical and legal options open to a company and to the agency concerned is crucial.

A high degree of sensitivity is required when proposing and executing the strategy and tactics needed to obtain marketing approval in a way which will satisfy the authorities and serve the best needs of the company.

Considerable care must be exercised if the best possible case is to be presented to the authorities for the company. It must be done without obscuring the facts, enabling the authorities to arrive at a proper and rightful conclusion regarding the safety, efficacy and quality of the product under application. Regulatory professionals must always exercise considerable judgement in the practice of their role. Integrity and the ability to inspire trust and confidence are valuable attributes.

Good regulatory people ‘make it happen’. Project management skills help to achieve the challenging goals they are set.They can work as part of multi-disciplinary teams and lead them when necessary.They can work under pressure and inspire and motivate others to do the same 

Regulations & Guidelines

At IPA we understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements at home and in the regulated foreign markets. We’ve tried to simplify things for you by assembling the important Indian and international guidelines and regulations in this section.

Indian Regulations & Guidelines:

CDSCO  Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India. NPPA Drugs (Price Control) Order 1995 and other orders enforced byNational Pharmaceutical Pricing Authority (NPPA),Government of India. View the list of drugs under price controlhere..... D & C Act, 1940 The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India. Schedule M Schedule Mof the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs. Schedule T Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines. Schedule Y The clinical trials legislative requirements are guided by specifications of Schedule Yof The D&C Act. GCP guidelines  The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR)has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice. The Pharmacy Act,1948  The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India. The Drugs and Magic Remedies (Objectionable  Advertisement) Act, 1954 The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities. The Narcotic Drugs and Psychotropic Substances  Act, 1985 The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances. Links to important international guidelines and regulatory bodies WHO (Medicines) WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines. WHO sites WHO guidelines on all areas relevant to health of people all over. ICH International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States OECD Organization for Economic Collaboration and Developmentincluding 30 member countries covers economic and social issues in areas of health care. EMEA European Medicines Agency (EMEA), a decentralised body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union. US FDA Regulations, guidelines, notifications, news and communications from US Food and Drug Administration. TGA Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body. South Africa The department of Health, South Africa. WTO News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations. Codex Alimentarius Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme. MHRA News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK. Health Canada Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada. Thai FDA Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics. HSA, Singapore Health Sciences Authority (HSA), the regulatory body of Singapore. DOH, Philippines The Department of Health, Philippines.  Medsafe,  New Zealand Medsafe, New Zealand Medicines and Medical Devices Safety Authority. NPCB, Malaysia Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia. DGMP, Belgium Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium. BfArM, Germany Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany SwissMedic Swiss regulatory agency for therapeutic products. MPA, Sweden Regulatory and surveillance guidelines issued by Medical Products Agency, Sweden. NAFDAC, Nigeria News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria.