1-Deleting the redundancy and overlap in approval procedures of clinical trials in preclinical requirements of the investigational products.
2-Defining in a clear manner the maximum timeline expected to obtain approval from the competent authorities before initiating a trial.
3- Defining a process for streamlining approvals for investigational medical product stock import for the logistical convenience of the trial initiation.
4-Enhancing the clarity regarding the procedures of bioequivalence studies.
5-Setting rules for membership, accreditation, training, functioning, capacity of reviewing protocol and monitoring studies of clinical trials review boards.[@16534] Clarifying the objectives and respective duties of national ethics boards, local ethics committees and institutional review boards. Defining an authority hierarchy. Ideally avoiding multiplicity/redundancy of such research ethics committees.
6- Defining simplified approval procedures for non-interventional (observational) studies.
7- Issuing a detailed pharmacovigilance guideline, consistent with the current international requirements, including homogenous timeline for reporting serious adverse events (SAEs), conditions of waiver of reporting protocol specified or study endpoints SAEs, conditions of reporting causality.[@16550]
8- Clarifying the need and process, if any, of certification of clinical trial sites.
9- Clarifying procedures governing informed consent, including the need of translation of consent forms, and managing transparent information and consent for illiterate[@16551] and vulnerable participants.
10- Setting a legal framework for biobanking and material transfer agreements, including across national borders.
11- In the context of genomics and biobanking research,[@16552] setting guidelines and governance frameworks of sample and data sharing, including de-identification processes, securing data protection, appropriateness of using broad consent and sample access for secondary use, feedback of individual genetic findings. Clarifying the justification of, and optimally waiving the prohibition of bio-specimen export, which impedes the principles of openness, storage, sharing and secondary use of biosamples.[@16553; @16554; @16555; @16556]
12-Revising the “criminal penalty”[@16557] regulation (“no-fault compensation for research-related injuries”). Assessing the occurrence of unexpected serious adverse events only in the light of its relatedness to the investigational product rather than the already pre-existing condition, and enacting a regulatory requirement for insurance-based compensation for biomedical research-related injuries.
13- Setting a legal framework and mechanisms for sponsors to provide long-term post-trial access to trials treatments proven beneficial.
14- Update subject privacy and data confidentiality legislation consistently with international standards.
15- Seek harmonization of technical requirements and guidelines for clinical trials across Middle East, Mediterranean and African countries.
16- Initiate the process toward an harmonized, overarching unified regulatory framework across the largest possible number of Middle East, Mediterranean and African countries.