Abstract
The Scope of Regulatory Affairs in the Pharmaceutical Industry
Hygeia.J.D.Med, 2(1), 2010, 1-6
Subash Philip and Ansa Philip
Crescent Collegeof Pharmaceutical Sciences, Payangadi, Kerala, India, 670 358
Received: 17January 2010, Accepted: 26 March 2010
The regulation of medical products has been expanding since early 20th century.Regulatory agencies are beingestablished in an ever increasing number of countries across the globe. Those that have established arereorganizing their systems and attempting to harmonize with organizations of otherCountries .The pharmaceutical, biotechnology and medical devices are among themost highly regulated industries in theworld. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinicalinstitutions. The Indian Pharmaceutical industry is one ofthe fastest growing industries in India, with a compounded annual growth rate(CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valuedat $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally. All companies engaged in R&D worth itssalt has an individual RA department toaid them in new product development. Theclinical research industry, which provides opportunities for RA professionals,is also growing at an unparalleled rate.It has opened up new vistas of employment for a large number of trainedprofessionals. The clinical trials market worldwide is worth over USD 52billion. A study by Ernst and Young indicates that the total market value ofClinical Research activities performed in India is expected to grow to aroundUSD 1.5-2 billion. There is expected to be a huge demand for qualified RA personnelin clinical research
International Regulatory Environment
Good Manufacturing Practices has been inpractice from Old Testament times (Laws of Kashrut). The Nuremberg Code, 1947on Permissible Medical Experiments provided for basic principles to conduct medicalexperiments on human beings followed by Declaration of Helsinki (1964) ,Belmont Report of USA (1978) and WHO GCP (1995) and ICH GCP in 1996. In 1959, Canada instituted its QUAD regulations,which is the first recognizable drug GMP of modern era. It was followed by GMPsof USA in 1963 and that of UK in 1972.
Today 35 member countries along with 11candidate countries and 4 international agencies have joined together to createthe Pharmaceutical Inspection Cooperation Scheme (PIC/S) to promote a globallyaccepted GMP. The International Conference on Harmonization (ICH) wasestablished in 1990 and has succeeded in harmonizing GMPs for manufacture ofActive Pharmaceutical Ingredient (API), validation of analytical methodology,guidelines for performance of stability studies, harmonization of pharmacopoeialmonographs and test methods and other guidelines of working of GMP.
Academic Prerequisites
Masters degree in Pharmacy withPharmaceutical Administration and Management or Regulatory Affairs specializationwill be the preferred qualification to qualify for as a RA professional. Withinthe curriculum he should have covered topics such as Handling laboratory andmanufacturing deviations, Pre approval inspections, impact of Total Qualityperformance, GMP Certification and enforcement actions, Maintenance and Updateof Product Master Files, Internal Compliance of Documentation, Coordination andAssembling of Common Technical Document (CTD/eCTD), Quality systems, QualityAssurance, Method Validations, Process Validations, Master Validation Plan,Protocols, Standard Operating Procedures (SOPs), Auditing and ComplianceFunctions, Regulatory strategies, Regulatory agencies, legislation anddocumentation systems as required for USFDA, UKMCA/UKMHRA, MCC, WHO etc., FDA/UKMHRAqueries and submission, application requirements and guidelines, electronic submissions,medical device regulations, stability asper ICH guidelines & Multi-brand registrations (MBRs); Internationalharmonization, practice of regulatory affairs, USP Pharmacological, Toxicologicaland Clinical Trial Information, Re-registration Documents Design, Role of theInternational Business Operations of the Pharmaceutical MNCs in Attracting theFDI, Clinical Pharmacy, Drug Trials and Vaccine Trials Guidelines, Drug Laws ,Investigational New Drug Applications? , Formatting, assembling and submittingthe New Drug Applications, Human Genetic Research, Clinical Trials, Indian EthicsCommittee, Good Clinical Practices (GCP), Pharmaco-vigilance and Adverse DrugReactions reporting, Clinical Trial Regulation, Intellectual Property Rights, Basis of Patentability,Patent Application Procedure, Compulsory License, Infringement of Patents,Product Registration for Regulated and Non Regulated Markets etc
Responsibilities
The responsibilities of RA personnel ingeneral can be summarized into three
(i) Ensuring that their companies comply with allof the regulations and laws pertaining to their business,
(ii) Working with federal, state andlocal regulatory agencies and personnel on specific issues affecting
their business
(iii) Advising companies on the regulatory aspects and climate that wouldaffect their proposed
activities.
In an marketing organization their primeresponsibilities involves preparation and presentation of registrationdocuments to regulatory agencies and carrying out all discussion to obtain andmaintain marketing authorization (MA) for the products concerned. They need tokeep track on ever changing legislation in all countries where the companies islooking to market their product. They play a pivotal role in facilitating thecommercial progression of new health products and technology through productlife cycle.
Skills
As regulatory affairs professional, theyare often responsible for tracking changes in regulatory guidelines as they mayoccur. In order to do this, they musttake the initiative to keep current on all changes in regulations. For example,they have to check the FDA Web site and read professional journals.
They can learn about new guidelines fromdifferent sources like peers, printreleases of regulatory authorities and by attending conferences. All changes inregulations must be documented in the manner required by the company. Changesmust also be interpreted and communicated to appropriate people in the company,including management. Management may then determine what changes in company proceduresand process may be required to stay in compliance. They are also involved withcoordinating and implementing the changes which calls for much sensitivity sothat changes suggested are smoothly accepted by the company’s management andthe regulatory bodies. They have a major contribution to make in company’ssuccess both commercially and scientifically.
Regulatory Affairs in Product Management
The key role of RA professional isbroader than registration of products, they advise companies both strategicallyand technically at the highest level. Their role begins right from developmentof a product to making, marketing and post marketing strategies. Their adviceat all stages both in terms of legal and technical requirements help companiessave a lot of time and money in developing the product and marketing the same.For countries that do not have their on regulations the World HealthOrganization guidelines on health matters and World Trade Organization on trade regulations between nations is followed
Regulatory Affairs in Clinical Trials
The RA professional is the primary linkbetween the company and worldwide regulatory agencies such as US Food and DrugAdministration (USFDA & Center forDevices and Radiological Health) Medicines and Healthcare Products RegulatoryAgency, United Kingdom, (UKMCA) , Therapeutic
Goods Administration, Australia
European Medicines Agency Organizationof Economic Collaboration and Development (OECD) and Health Canada . He alsocommunicates and interprets theseemingly endless mace of laws, regulations and guidelines to the otherdepartments of the company. The RApersonnel develops strategies to overcome delays and presents finding ofclinical trials to the regulatory bodies so as to get quick clearance thusreducing the time for approval of new molecules. At its core, the RAprofessional facilitates the collection, analysis and communication about therisks and benefits of health products to the regulatory agencies, medical andhealth systems and the public. Operationally RA is responsible for assuringthat government obligation, market driven demands and evolving scientificconventions are understood and addressed by various stakeholders.
Regulatory Affairs in R&D
The regulatory affairs personnel workhand in hand with marketing and R&D to develop, innovative products thattake advantage of new technological and regulatory developments to acceleratetime to market. With new products expected to add significant revenues to thecompany’s bottom lines, small decreases in time to market equate to largematerial gains in revenue and profit. Employing adaptive clinical trialstrategies, obtaining quick approval from regulatory authorities and avoidingpitfalls in processes can acceleratedevelopment of new products and help to reduce costly errors and time lags Changesin regulatory environment Guidelines on clinical trials for import andmanufacture of new drug was introduced in the Drugs and Cosmetics Rules as Schedule Y in 1998. This heralded the entryof clinical trials organization like Quintiles into India and encouraged thepharmaceutical industry to conduct phase III trials. Ethical Guidelines for Biomedical Research onHuman subjects was brought by Indian Council of Medical Research (ICMR) in2000. Good Clinical Practices were adopted by India in 2001 by Central Drugs
Standard Control Organization (CDSCO)
. The National Institute of MedicalStatistics of ICMR also set up a clinical trails registry in 2009. A newamendment to the Drugs & Cosmetics Act is seeking to replace the CentralDrugs & Services Control Organization (CDSCO) with the Central DrugAuthority (CDA) comprising of Drugs Controller General of India as the chairman and five other members
Ten departments will be controlled bythe authority include regulatory affairs, imports, new drugs, biotech products,pharmacovigilance, medical devices and diagnostics, organizational services,training, quality control and legal & consumer affairs. Moreover new billfor regulation of medical devices industry is also in the gambit. MedicalDevices Regulatory authority is a body; government is yet to implement to regulatethe ballooning medical devices industry whose products are largely approved inother countries and eventually finds entry into Indian market
Regulatory Scenario of Herbal Medicines
With the Drugs and Cosmetics (Amendment)Act of 1964, the definition of Ayurveda, Siddha andUnani (ASU) medicines wereintroduced into the perview of the Act and all necessary provisions for controlof this class of drugs were introduced . According to the law licence isrequired for manufacture of ASU drugs but exempts the same for sale provided drugs are manufacturedunder licence, appropriate labeling and packaging are also necessary formarketing these products
GMP implemented Schedule T
for manufacturing plants of ASU drugs.In foreign countries premarketing approval and documentation to
prove efficacy and safety is requiredbefore approval of herbal products
Conclusion
Regulatory Affairs within the biomedicaland health products sector is a relatively young, multidimensional professionthat is international in scope. RA professionals come from a variety ofdisciplinessuch as law, academics, industrial research and medicine. It is a promisingfield for scientists searching for alternative careers because it offers amultitude of jobs and opportunities for development. The modern view of RA as adynamic, business oriented unit, focused on getting products to the market witha commercially viable label as quickly as possible is a visionary andcompetitive paradigm.With increasing outsourcing of jobs to India coupled withflamboyant salaries, burgeoning technically educated middle class proficient inEnglish, the regulatory affairs industry is poised for rapid growth. RegulatoryAffairs, therefore, promises to be an interesting career option in India forpharmacy graduates. It will definitely pave the way for greater development andintegration of careers with the global workforce and improve the competenciesof graduates in the country.