The authorization process of introducing new drugs is rigorous and careful, particularly in countries where the regulatory framework is underdeveloped. Middle Eastern health authorities have made their steps to ensure the safety, quality, and efficacy of drugs entering the population. These steps are improving public health, but they represent a formal process by which companies must approach carefully to gain successful authorization.
It is important that pharmaceutical companies, regulators, and potential entrants seeking successful market entry know how the drug approval process functions in this market. From submission to post-approval monitoring, this article outlines the important steps of the process and what needs to be documented.
The Importance of Regulating
Middle Eastern health authorities have put in place comprehensive systems that oversee the assessment, approval, and oversight of medical products. The authorities are pivotal in:
- Ensuring the safety and efficacy of medicines for the safeguarding of public health
- Facilitating review process transparency
- Facilitating innovation through timely approval processes.
- Working hand in hand with international standards while addressing regional health issues.
The process of authorization is usually used to prescribe medications, over-the-counter drugs, biologics, and sometimes traditional and herbal therapy.
Pre-Submission Planning: Getting It Right from the Start
Even before filing, pharmaceutical companies have to become familiar with the regulations itself before making the application to the destination country. While guidance of regulation in the Middle East varies, the majority of states are moving in the direction of harmonization towards the universal standards by organizations such as the ICH (International Council for Harmonisation) and the WHO.
In the planning stage, first and foremost, is having ready an up-to-date dossier that contains
- Results of clinical and pre-clinical tests
- Product and process of manufacture
- Risk management approach
- Labelling and packaging information
Pre-submission consultation, if offered, is highly recommended for setting expectations and reviewing technical details.
The Dossier Submission and Review Process
Upon filing the dossier, the regulatory agency initiates the overall review process. This can include:
- Administrative review for completeness
- Scientific review of clinical data
- Review of manufacturing and quality control processes
- Risk assessment – benefit risks
Review times vary by product, the quality of the application, and the workload of the regulatory agency. Accelerated or priority review is also available for other products meeting serious public health needs.
In countries with a centralized or semi-centralized system of assessment, a favorable in one nation will have an effect on others’ decision-making, especially within the GCC nations. However, each nation still has sovereign rights to accept or reject applications.
Local Registration Requirements
Besides the dossier of science, most regional regulatory authorities also ask for supporting documentation that attests to compliance at the local level. These are usually
- Certificates of Pharmaceutical Product (CPP)
- Manufacturer authorized or apostilled documents
- Pharmacovigilance undertakings
- Representation by a local agent or sponsor
One of the best-known regulatory systems in the area is the SFDA registration system, which includes stringent testing requirements for products. Going around the system not only provides access to one of the largest healthcare markets in the area but also achieves conformity with one of the more formalized regulatory bodies in the Middle East.
Post-Approval Responsibilities
Authorization is merely the start of the regulatory process. Once a drug has been authorized for marketing, it falls under post-marketing surveillance. This comprises continuous safety monitoring, periodic adverse drug reaction reporting, and manufacturing change reporting.
Pharmaceutical companies are required to keep the regulatory bodies informed and meet requirements such as:
- Submission of periodic safety update reports (PSURS)
- Product labelling or pack reporting
- Action on any new safety notifications occurring
It can lead to fines, product recall, or even license revocation if such post-approval obligations are not fulfilled.
Issues for the region
While the approval procedures of Middle Eastern medicine are being developed at a fast pace, the applicants can encounter some or all of the issues discussed below:
- Language and Translation Problems: English and Arabic language documents are typically submitted to most countries.
- Regulatory Updates: Specifications and technical guidelines often evolve from time to time for which the applicants should remain up-to-date and dynamic.
- Local Presence: The necessity of maintaining a local representative or sponsor in nearly all the nations can become troublesome for institutions without regional presence.
- Unrealistic Timelines: Depending on the product category, some applications may take 12–24 months or longer to be processed, especially if clarification or further data is required.
Bringing Everything Together
The Middle Eastern pharmaceuticals approval process is dynamic and progressive. While local regulatory processes strive to follow best practices in the world, they also respond to the specific health needs of each country in addition to country regulations. Pharmaceutical companies can easily navigate this process by staying one step ahead through perseverance and putting resources into regulation while following local regulations as well as international standards.
Whether it involves SFDA registration preparation, acquisition of local representation, or compliance with post-market surveillance, quality regulatory strategy determines successful market entry. With appropriate knowledge and foresight, all stakeholders can enable improved health benefits in the country while enabling on-time access to safe and efficient drugs.
