المملكة: “Periodic reports and mandatory plan” .. the most prominent updates of the pharmaceutical awakening guide

The Food and Drug General Authority has announced the proposal of a guide to the foundations of good practices to awaken through the “poll” platform, with the aim of enhancing the safety and effectiveness of registered and marketed pharmaceutical products in the Kingdom, and providing instructions and criteria that contribute to reducing the risks associated with the use of medicines, and improving the level of public health by ensuring the use of safe and effective products at the individual and societal levels.
The new updates offered by the authority included fundamental amendments and additions to the procedures and requirements of drug awakening, including the standard schedule for the submission of PSUR/PRER reports.
As items of marketing licenses “MAH” must submit these reports either via allocated e -mail or through a built -in disk, according to the specific requirements for drugs that contain new chemical entities or similar biological and biological products, as well as the generic drugs registered for the first time, and licensing holders were obligated to send the reports submission plan annually to ensure compliance with organizational standards The updated.

A comprehensive report

The authority deleted the condition of submitting a comprehensive report to evaluate the potential signal at its request, within the department concerned with the measures taken during the report period for safety reasons.
The requirements of the Saudi supplement «SSA” was also updated within the risk management plans «RMP), as it became necessary to submit it when the European RMP was presented during the registration phase before marketing, and also at any subsequent updates during the post -marketing stage.
The updates also included fundamental adjustments to the requirements of applicants and licensing holders, as the submission of SSA became mandatory during the registration stages before marketing and beyond when updating the RMP or when requesting it.

Fundamental change

The commission made an update on the requirements for submitting RMP when there are changes in the marketing license, so that companies must be submitted if there is a fundamental change in the significance of use, dose, or the method of giving, or in manufacturing processes for biological products.
In a step to enhance the smoothness of communication, the email designated for the submission of RMP was modified after the license, and the authority added new requirements to attach a professional translation license when submitting Arabic copies to educational materials. In addition, the criteria for coordinating educational materials have been updated so that the initial draft is presented in editing formulas, then the version designed for the final approval is presented.

New requirements

Among the prominent additions in the guide is the imposition of new training requirements on people responsible for drug awakening «QPV), as it has become necessary for training to include specialized standards such as Meddra coding, analysis of negative events reports, evaluation of the causal relationship, quality management, the principles of pharmaceutical epidemics, and communication on the risks« DHPC).
The period of time required to update training was also modified from two to three years, to ensure the continuity of the efficiency and qualification of specialized cadres in this field.
In terms of enhancing transparency, the authority obliges licenses to create an electronic page in Arabic that contains communication channels with local QPV, and can include models to report side effects.
New requirements have also been imposed to register those responsible for drug awakening and their deputies through the Saudi vigilance system, while providing official documents proving their approval and training in the field.

Product safety

Regarding local databases systems, licensing holders have become obligated to conform to locally iCSRS reports in the period periodically, to ensure the completion of the database and safety of the traded products.
The commission canceled the previous requirements related to following up the safety signals issued by some international regulatory authorities such as EMA, FDA and MHRA, and replaced them by obliging companies to take measures based on safety signals issued by any body listed on the list of the WHO authorities.
The commission has set a maximum period of 21 days to submit a SPC/PIL update request when it is requested from any party listed in the WHO-Llas list, while a deadline of up to 180 days was granted to submit the signal evaluation report if the application comes from other international organizational bodies that are not listed in the list.