Background: The purpose of this study was to determine the values and disadvantages of outsourcing regulatory affairs tasks in the pharmaceutical industry. The aim was also to study how many CROs the pharmaceutical companies outsource regulatory affairs tasks to and the duration of outsourcing partnerships between companies and CROs.

Method: The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany and Spain focusing on those companies that undertake regulatory affairs.

Results: The survey received 71 completed responses out of 147, a response rate of 48%. According to the responses, 65% of the pharmaceutical companies have outsourced tasks related to research and development over the last three to five years. Over 44% of the respondents informed that they have outsourced to one or two CROs only. One quarter of the respondents have outsourced to three to five CROs. Most (91%) of the respondents in the pharmaceutical industry strongly agree and agree on the fact that they outsource the regulatory affairs tasks because they want to obtain greater flexibility. The companies evaluated that outsourcing to CROs is expensive (strongly agree or agree 74%).

Conclusion: CROs have to keep the qualitative level high and obtain flexibility towards the companies. When a company is considering outsourcing regulatory tasks, planning has to be done well in advance. The main topics to be discussed between the company and CRO before outsourcing process are the estimated costs of the outsourcing, outsourcing strategy, information flow and audit trails.

The objective of the study is to assess the Indian perspective of nourishment through regulatory guidelines for quality system prescribed during manufacturing operations managed at plant level and distribution managed by supply chain management beyond manufacturing premises. Good Manufacturing Practices (GMP) and Good distribution Practices (GDP) are two prominent regulatory guidelines available to manage them within plant and outside plant respectively.

Method: The method study shall be exploratory studies based on data and facts derived from government organizations, regulatory bodies and scholarly literatures available on the subject matter. Indian government has reinforced the sampling of market samples for analysis in order to assess their quality. The product sample analysis results by CDSCO of Government of India has been analyzed to estimate the types of quality defects, in addition to making use of information from relevant literatures.

Results: The review of existing legislations available to directly or indirectly manage quality of pharmaceutical products, it is found that regulations are more centered towards the manufacturing operation, if quality is taken into consideration. There is need to maintain the overall quality of products by taking care during manufacturing process as well as during distribution operations, hence the linkage between regulatory guidance for these two operations must be established effectively.

Conclusion: The existing design of system is discrete with respect to management of quality during manufacturing and distribution operations for pharmaceutical products. Regulatory bodies are recommended to reinforce the effective linkage in regulations for manufacturing and distribution system through working paper, technical report series and or regulatory guidance.

Background: The implementation of GMP requirements in Sudan as developing country imposes pressure on both the manufacturers and regulatory authorities since resources are limited and additional regulatory and manufacturing facilities are required.

Objective: The study aimed to assess the regulatory affairs of pharmaceutical good manufacturing practice in Sudan.

Method: A structured questionnaire was given to the secretary general of the Sudanese National Medicines and Poisons Board (NMPB). Other different questionnaire was conducted to get information from manufacturers. The study questionnaire was validated and analyzed using SPSS software version 20.

Results: The study findings from authority displayed a satisfactory relation between the manufacturers and regulatory authority. In contrast majority of manufacturers (5 out of 7) were not satisfied. Four of manufacturers were strongly agreed and agree with the Sudanese drug registration guidelines. Two of manufacturer’s complaints on delay of medicines release. It was found that there is a lack of local GMP regulatory documents. There is an absence of regulations regarding the reporting of the side effects of medicines by doctors or pharmacists. Capacity shortage is considered as the main problem faced by the Sudanese authority. Controlling the price of medicines is one of the functions of the NMPB.

Conclusion: To strengthen the relation between the manufacturers and regulatory body there is need to enhance the efficiency of meeting. Local GMP guidelines are necessary to improve the application of current regulations. Lack of training personnel and shortage of facilities in pharmaceutical factories exert difficulty in implementation of require GMP. Adoption of a law to report the side effects improve the safety of medicines. NMPB pricing system helps in minimizing escalating GMP implementation costs, but it affected by economic instability. Government support, enhancement of technical cooperation and information exchange with other authorities in different countries will speed up improvement in the GMP regulatory status in Sudan.