Question

Given the diversity in Regulations in the foreign countries, how might increased US involvement in ICH activities help alleviate some of the product quality occasionally observed in products entering the US market?

Answer 1

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. Since its announcement of organisational changes in October 2015, ICH has grown as an organisation and now includes 17 Members and 32 Observers.

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development.

The pharmaceutical industry is one of the highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public. Therefore, the aim of the pharmaceutical industry is to identify and develop a generic drug product which can be tailor made to meet the diverse market requirements. As per global market trend, it is estimated that approximately $150 billion worth of drugs will be off-patented during the period 2010 to 2017, which will serve as a platform for pharmaceutical companies to develop generic drugs.[1] The pharmaceutical industry in India has shown a remarkable growth which in turn has risen the economy of India.[2] After the introduction of the product patent regime in India, there was a need for pharmaceutical companies both in India and abroad to explore newer markets. Indian pharma majors are entering new markets with global ambitions, mergers and acquisitions are in focus with a reason to enter new market. For sustained growth over the next few decades, firms have to concentrate on generic drug products. “Diseases that cannot be cured, diseases that have to be managed, provide great opportunities for generic drugs.” Government has the responsibility to protect their citizens. It is the responsibility of national governments to establish regulatory authorities with strong guidelines for quality assurance and drug regulations in the respective territories. Somewhat parallel with the ongoing harmonization and movement toward creating a common market for medicines inside the EU, the need for wider harmonization was felt by officials from Japan, EU, and US during International Conference of Drug Regulatory Authorities (ICDRA) organized by world health organization (WHO). The informal discussions had led to a need of the harmonization of requirements relating to the new innovative drugs and also subsequently paved the wayto the establishment of International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), a collaborative initiative between the EU, Japan, and the United States with observers from WHO, EFTA, and Canada. Efforts to harmonize various elements of drug regulatory activities have been initiated by various inter-governmental organizations at regional and inter-regional level in the past decade. The driving force behind these efforts has been the increase in global trade in pharmaceutical products, and growth in the complexity of technical regulations related to drug efficacy, safety, and quality

Status as of today: Due to the emerging regulatory needs of pharmaceutical sector, the drug evaluation for the control of drug quality and trade has become highly sophisticated. Regulatory guidelines and standard tools provide a basis for implementation of laws, whereas laws provide a legal basis for drug control. The world covers more than 100 countries, where most of them have established pharmaceutical legislations and regulatory requirements. For worldwide regulatory dossier submissions, it is a pre-requisite requirement to have a knowledge of country specific guidelines and norms. Therefore, it is very important to analyze the differences and commonness between the regulatory requirements and pharmaceutical legislations of different countries of the world. The Pharmaceutical market based on the diversity in the regulation region and marketing interest can be divided into two groups: Regulated and emerging markets. The regulated market involves those countries where there are defined regulatory requirements set by the regulatory bodies of that country and the emerging market countries are those who still lag behind in putting forward the well defined regulations for drugs. United States (US) and the EU are the biggest and the most potential markets for in the world and are categorized under the regulated markets, whereas ROW (Rest of the World) market includes all the emerging markets like Brazil (LATAM), Tanzania (Africa), Russia (CIS), Hong Kong (ASIA), etc.

USA is the major market for the pharmaceutical industry. The USA has evolved from no regulations in the 18th century to one of the highly regulated and admired regulatory authority in the world. The food and drug administration (FDA) within the U.S. Department of Health and Human Services regulates the drug approval system in United States with help of six product centers including Center for Drug Evaluation and Research (CDER).[5] Drug registration in USA is majorly categorized by two types of applications: New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). ANDA is filled for generic drug products; those require marketing authorization and are of exact or close copies of already approved drugs.[6] The ANDA approval process is depicted in Figure 1[7] Indeed, the way this country regulates drugs typically has been born out of adversity, out of events that have killed and injured thousands. The evolution of the current drug regulatory system in USA is recognized globally as the gold standard for drug safety and efficacy. During 1990, FDA began work to develop standards for the exchange of electronic information critical to the agency's mission. This recognized both the inefficiency of paper for transferring mass quantities of data and the need to develop a harmonized format that would be usable by FDA as well as its counterparts in the European Union and Japan. Consequently, firms are now able to submit paperless product applications and related material to world regulatory agencies more efficiently, while each review authority maintains its own high standards for product evaluation. Because all drugs have some risk, FDA task force advised the agency to make more systematic use of the principles of risk management in the way FDA oversees drug development and marketing