Pharmaceutical regulations across the globe play an important role in ensuring the safety and effectiveness of medications. They not only monitor the pricing of medications but more importantly, they ensure quality and effectiveness as well. Every country has some form of its own regulations in place which apply to many areas including testing, transportation, and storage.
But what happens on the global distribution level?
Pharmaceutical regulations have been established at the national, regional, and global levels. Each of these areas has its own individual objective, structure, and process, but they all move towards the same goal: The promotion of public health with a consistent decision-making process. These processes establish patient access to safe and effective medicines. However, if these efforts are not well coordinated, the duplication of work and new standards could cause a problem. To be successful, global systems need to incorporate all levels of regulations and combine them into an overarching global authority.
In almost every industry, including the pharmaceutical industry, some form of globalization is present. Products sold in one country could be made up of components supplied from every corner of the world. In 2017, the United States imported 110 billion dollars worth of pharmaceuticals, 50 percent of clinical thermometers were produced in India, and Japan sits at the top of the leaderboard for global pharmaceutical exports.
Because of this global network, national regulators are now giving thought to globalization when ensuring products in their markets are safe, efficacious and manufactured in accordance with prescribed quality standards.
Today’s regulation system is characterized by increasing levels of harmonization. One example of this is Mutual Recognition Agreements (MRA’s). These are international agreements by which two or more countries agree to recognize a specific process or procedure of the other country.
In 1998, a Mutual Recognition Agreement between the European Union and the United States (U.S.-EU MRA) was signed, which included a Pharmaceutical Annex providing for recognition of each other’s GMP inspections. In 2017, the Sectoral Annex was amended to allow for the FDA and the EU inspectorates to use reports and other related information obtained during drug manufacturing facility inspections to help determine whether a facility is manufacturing with high-quality compliance practices. Then, if necessary, the FDA or EU can require further inspection or take other action to protect the public. These agreements set a baseline for global regulation and are excellent first steps to increased harmonization, but this is just the beginning.
Key players in harmonization are global bodies, such as the World Health Organization (WHO) and the International Council for Harmonization (ICH). These organizations work to achieve global consensus in developing regulatory guidelines. Global initiatives like the ICH and the WHO are becoming increasingly important, but they rely on the already well-established system of regional agreements. Regional initiatives are key to relaying information from individual countries to the global level. Countries with no regulatory system in place or with a small regulation staff cannot be expected to execute at the same caliber as organizations like the FDA.
Nonetheless, their needs must be taken into account when considering global regulations. Coordinating, structuring, and utilizing current regional cooperations make the transition to global cooperation and harmonization of pharmaceutical regulations much easier. Our leaders and regulatory authorities have a mandate to improve public health, and the best way to support global health is to support common high standards.