The Processes of Drug Registration in the Context of the United States - Article Example

Name Professor Course Date Saudi FDA Drug Registration Processes Introduction I have chosen this topic because I have substantive knowledge about drugs having studied drug regulatory affairs in the context of the United States. In addition, I have worked at Saudi FDA for two years; hence, it is going to be an interesting aspect comparing drug regulation concepts between the two agencies: an agency in developed country (FDA) and an agency from developing countries (SFDA). This paper focuses on evaluation of the SFDA, the processes of drug registration, differences between American FDA and SFDA, and some recommendations to enhance the SFDA. Method This paper has been essential in evaluating data from SFDA website, regulatory framework for drug approval in SFDA website, and guidance for Priority Review of Product Registration. These guidelines contain hundreds of hundreds of pages. I collected and summarized these guidelines for effectiveness and efficiency in reading and grasping relevant concepts with reference to drug regulations and registrations. Overview of SFDA Having been established in 2003, SFDA sought to regulate, oversee, and control food, drug, and medical devices establishments in the context of Saudi Arabia. In addition, SFDA focuses on the development and implementation of mandatory standard specifications for the locally and internationally manufactured drug products. SFDA executes control and testing activities in its laboratories as well as other laboratories belonging to diverse agencies. Furthermore, SFDA controls the consumers’ awareness concerning food, drug, and medical-related matters such as products and supplies. SFDA’s vision focuses on being the regional leader in regulation of drugs, food, and medical components while integrating professional as well as excellent services contributing to advance protection and healthy conditions in Saudi Arabia. On the other hand, the institution’s mission is to promote safety of food by integrating regulations to enhance quality, safety, and efficacy of drugs as well as effectiveness of the medical components and devices in accordance with the appropriate regulatory systems. SFDA has three critical sectors to aid its operations: Food, Drug, and Medical Devices. Drug’s Departments The National Drug and Poison Information Center (NDPIC)  Executive Directorate of Communication and awareness Vigilance and Crisis Management Executive Directorate Cosmetic Directorate Licensing Directorate The Executive Directorate of Laboratories  Executive Directorate of Inspection and Law Enforcement Executive Directorate of Product Evaluation & Standard Setting SFDA Drug Registration Process Phase I 1. Registering at DENR website(denr.sfda.gov.sa) The Drug Establishments National Registry (DENR) comes out as an electronic system with the aim of generating a national database in relation to all drug establishments with reference to international and local business entities, agents, manufacturers, and wholesale distributors in the context of Saudi Arabia. It takes approximately one week for these entities to obtain a username and password from DENR. DENR sends an email with a username and password to the entities facilitating their movement to the second phase of the registration. 2. Submission at SDR website (sdr.sdfa.gov.sa) In this second phase, SFDA utilizes an electronic system in the form of Saudi Drug Registration to facilitate registration of medicinal, herbal, and health products for the veterinary as well as human use. There are three critical applications in this stage: Marketing Authorization Application of Medicinal Product for Human Use, MAA of Herbal and Health Product, and MAA of Medicinal Product for Veterinary Use. 3. Paying the Fee This process is similar to the application fee paid to the PDUFA in the context of the United States, but different amount. In order to complete the registration process, the entities must pay an application fee of approximately $25,000. 4. Appointment with FDA The next step toward registration is scheduling an appointment with the FDA with the aim of delivering the hard and soft copy of the product. Entities have the opportunity to schedule an appointment between one and twelve weeks in advance for effectiveness and efficiency. In addition, the application has the opportunity and capacity to reschedule seven days prior to the appointment. 5. Phase I’s Validation During the validation phase, the drug sector will concentrate on validation of the three components: application form, product file (soft and hard copies), and the samples in accordance with the demands and regulations of the sector. 6. Acknowledgement Letter Successful validation of the above components would result in the generation and provision of the acknowledgement letter to the applicant. This makes the drug application to enter to the queue. Phase I Pathway Chart Completion of these steps indicates that the application has adhered to the requirement processes making the application to be at SFDA. On the other hand, the applicants have the obligation of reply in relation to any information missing or emerging questions from SFDA. Phase II Following the submission and receivership of the ideal items, MAA will comply with the following processes. i. Validation This process focuses on the validation of the product file with the aim of ensuring that the information adheres to the requirements and guidelines. In addition, completed file proceeds to the assessment process. In case of any missing information, the applicant will obtain a notification through electronic system. In this context, the applicant will have two months to provide the missing information or face rejection of the file. ii. Assessment It is essential to note that the process distributes the product file in two diverse groups: efficacy and quality. Quality assessment is under the assessment or evaluation by a quality group prior to being forwarded to the product manager upon completion. On the other hand, efficacy group will execute efficacy assessment prior to being forwarded to the product manager upon completion. In case of any need for clarification, the product manager will have the obligation of forwarding an ‘inquiry form’ to the applicant expecting a response within 30 days or the fateful rejection of the application. Finally, the product manager forwards recommendation for approval or rejection letter to the Director of the Product Licensing department. iii. Pricing The pricing unit will utilize SFDA’s pricing rules in determining the price. In this case, the product manager would send an ‘inquiry form’ while requiring information from the applicant expecting a response within 30 days. The unit writes and forwards the final price to the product manager. iv. Testing SFDA will focus on testing all the samples received at the headquarters to the laboratory. Any missing information would result in the generation of the ‘inquiry form’ through the product manager with an expectation of a response within 30 days. This leads to writing and forwarding of the report to the product manager. v. Inspection The product manager will have the obligation of sending a Site Master File (SMF) to the inspection unit. Like in the above stages, the ‘inquiry form’ will come into play towards sourcing information within 30 days. Upon receiving this information, the inspection unit will focus on evaluation whether manufacturing line is approved or not. For instance, it the manufacturing line is approved through valid certificate from KSA Ministry of Health (MOH) or SFDA, the manufacturing line will not undergo assessment or inspection. This will prompt the head of the inspection unit to pass this information to the product manager. On the other hand, if the manufacturing line is not approved, the head of the inspection unit will focus on scheduling an inspection visit in accordance with the availability of the inspectors and the company. The end product of this process would relate to a report to the Head of Inspection Unit prior to sending of the report to the company’s product manager. vi. Product Licensing Upon receiving all reports from the product manager by the Secretary of the Registration Committee, the registration committee will have the opportunity to recommend an approval, rejection, or request for further information in case of need. In case of approval by the committee, SFDA Vice President will receive the minutes of the committee with the aim of issuing marketing authorization. vii. Appeal Process It is essential to note that the applicant has the right to appeal within 30 days of the final decision by the SFDA. Phase II Pathway Chart Target Time Type of MAA Target Time Generics 165 * New Chemical Entity (NCE) 290 * Biological 290* Radiopharmaceuticals 290* Veterinary drugs 195* Herbal & Health Products 155* All days mean working Days The clock stops when SFDA asks a drug company for an information FDA & SFDA SFDA and FDA have various differences and similarities. The main similarity relates to the mission statements aiming to ensure the safety of food, quality, and efficacy of drugs as well as quality and effectiveness of the medical devices in relation to adequate regulatory systems. Another similarity relates to the information as well as recommendations with reference to regulations. These occur in warning for diverse products. For instance, in case of a warning announcement by FDA on a product, SDFA must also announce the warning for effectiveness and efficiency in the service delivery. Nevertheless, FDA and SFDA have various differences in the registration requirements in accordance with the following instances: Alcohol & Pork-Free declaration SDFA requires mentioning of the Alcohol and Pork-Free declaration in the common technical documents (CTD) thus mandatory mentioning in the module 1, which is regional administrative information module. Saudi GMP Saudi Arabia operates on its personal GMP guidelines based on the European GMP guidelines with slight modifications. The drug manufacturers must adhere to the Saudi GMP requirements registered in the SFDA. For GMP inspections, domestic institutions must undergo assessment after every two years while international companies adhere to the five years assessment period. Orphan drugs & the exempted drugs SFDA operates on a list of products exempted from pharmaceutical as well as inspection services fees. The list undergoes frequent modification and updating in accordance with the Saudi Market. The list consists of 81 drugs divided into oral medications, injectable medication, controlled psychotropic medications, and narcotic medications existing under priority review processes. Priority Review These guidelines have the ability to facilitate as well as expedite the review of the new drugs or indications towards treating serious and life threatening conditions and unmet medical needs under the exempted drugs list with reference to SFDA. The review provides an opportunity for the concerned departments to place any drug designated for the priority review in relation to the head of the queue. Designation of the drug as a priority review does not alter the scientific standards for essential approval as well as the quality of evidence necessary for approval. Submission should be done prior to the original submission in order to have approval of the applicant’s claim. SFDA will focus on responding to the request to the priority review designation within 15 working days of the receipt of the request. The review clock will not offset until the product is accepted to for the approval of the priority review. The total performance target is reduced by 40 percent in relation to the normal registration processes. Conclusion In general, Marketing Authorization Application (MAA) does not take a lot of time comparing with the history of drug’s registration in Saudi Arabia and across the globe. The processes of registration, which includes phase I and phase II, is almost the same as the registration in United States and other global agencies. However, some processes or documents are required only in SFDA as Alcohol and Pork-Free declaration must be mentioned in the CTD module 1 and manufacturers that want to register their products in SFDA must meet Saudi’s GMP. In addition, SFDA has some drugs are exempted from pharmaceutical and inspection services fees and exist under priority review processes. This means the total performance target is reduced by 40% of the normal registration processes. Read More