According to the supplementary MoU, the two exchanges will establish a regular market regulation and research mechanism, discuss in depth hot topics on trading regulation, strengthen mutual learning and reference of experience in trading regulation and work together to improve market regulation.
The seminar, as another innovative move in the cooperation between the two parties, furthered exchanges on market regulation between the two. During the seminar, SZSE and KRX had thorough discussions on topics that both parties were concerned with such as prevention and control of speculation risk of theme stocks and concept stocks and discovery and handling of insider trading.
In recent years, the two exchanges have, by making full use of technological advantages such as big data and artificial intelligence AI , enhanced trading regulation in the monitoring of theme stocks and concept stocks and the investigation and handling of insider trading, through which they have developed relevant mechanisms, measures and practices with their own characteristics.
The two exchanges will continue to sum up relevant experience, improve existing communication and cooperation mechanisms and carry out communication and cooperation on an institutionalized and regular basis. Although the scopes of the inspections were not taken into account and different scopes may justify several of the "duplicate inspections", the figures collected from the retrospective data submitted confirmed a tendency of the participating regulators to perform duplicate inspections in third countries during the 3 years prior to the start of the pilot programme.
The pilot phase was initially intended to last for 18 months from the date it became operational but as setting up the practical details to implement the project took more time than expected it was decided in November during a plenary meeting of the pilot programme's participants in Washington to extend the pilot for an additional 6 months until December Hereafter a final report on the outcomes of the pilot programme would be published, including a recommendation for future action.
In addition it was decided to publish an interim report after the date when the programme was originally supposed to end June The tool which was the most used during the pilot, because easily organised, was the exchange of inspection reports from past or planned inspections, but without extension of the scope. The extension of the scope of a planned inspection was only used twice because it was difficult for the inspectors to cover more products than initially planned, mainly for logistic and administrative reasons, but also due to constraints on duration of the inspection.
Although the planning of joint inspections required extensive organisation and collaboration between the inspectors as well as with the site to be inspected, several joint inspections were organised and considered successful as the inspection team agreed on the conclusions and on a common list of GMP deficiencies on every occasion.
Work sharing was made possible through frequent and regular use of bilateral or plenary teleconferences as well as by the exchange of countless e-mails. A so called "Master List" was built up at the very start of the Pilot programme with initial information on API manufacturing sites Name, address, API s manufactured, last inspection date and outcome, planned inspection date This list was regularly amended by additional information provided regularly by the participants: new sites, new inspection dates, planned inspection dates and APIs manufactured.
The EMA assumed responsibility for updating regularly the Master list, including for tracking purposes, the relevant activities proposed for each site, e. Feed back forms were developed and distributed to the inspectors in order to identify possible differences between an inspection done by a national team of inspectors and an inspection done by an international team.
Inspectors were also asked to identify and report on all issues faced during the joint inspections, make recommendations when relevant and also report on the experience gained. No notable differences were identified and reported by the inspectors during the preparation, conduct and conclusion of the joint inspections. However the issues which were raised already during the earliest inspections were on the necessity to foresee, in addition to preparatory teleconferences, meetings before the inspection for preparation involving all inspectors of the team and after the inspection, to discuss and agree on the deviations and the conclusion.
This was considered especially important when the inspectors in the team were working together for the first time. The key element which provided increased transparency and visibility was the elaboration, based on the contributions of all participants, the maintenance and sharing of the Master List which recorded the sites of interest for the participants including when available the APIs produced at the site, the date and outcome of the last and the date of the next, planned, inspection by any of the participants.
By the end of the pilot the participants had submitted the following inspection information into the Master List:. The entries corresponded partly to sites inspected between and and partly to sites planned to be inspected as part of the and inspection programmes of the participants. As several sites submitted by the participants were sites shared by more than one participant, the Master List finally consisted of a total of sites of which sites were of interest to one of the participants only and were sites of shared interest to 2 or 3 of the participants; these were therefore the sites on which collaboration was possible.
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Based on the information available at the end of the pilot in December , the table below shows how the shared sites were distributed between the participants:. For the majority of the sites, the Master List also provided the inspection dates and outcome of inspections performed during and About inspections were performed on sites listed in the Master List by the participants of the 3 regions, Australia, Europe, and US during the pilot period.
The inspection dates and outcomes were submitted by the participants and this information could be used by all participants to request inspection reports. Conclusion : thanks to all the information organized and easily available such as listing of sites, details of APIs manufactured, last inspection date, next planned inspection date, shared by all participants, an increase in transparency and visibility of inspection activities was achieved. In addition to the sharing of inspection reports which increased the number of inspections of value for more than one authority see next section , a total of 9 joint inspections, were organised.
The joint inspection which allows two authorities to share resources by sending one shared inspection team to the same company helps to avoid duplicate inspections which require more resources from the inspectorates and from the sites inspected twice instead of once. However, it was noted that, particularly in when the programme was still at the beginning, and the tools not yet fully developed and in use, a number of duplicate inspections were still performed.
This was less evident in Conclusion: efforts to reduce the number of duplicate inspections should be continued as it allows saving costly inspectional resources and it also reduces the number of repeated often similar inspections to which the API manufactures are subjected. The exchange of inspection-related information included in the Master List allowed participants to know about inspections performed by other participants and their outcome. Whenever more information was needed a copy of the inspection report could be requested. Based on the information available on the planning of inspections, the participants could also contact each other to ask for an already planned inspection to have its scope extended so that the inspection would cover more products and therefore be of value for more than one authority.
Close to reports were exchanged and examined by the participants. According to the feed back received, the information contained in the report was used for different purposes. Although, from a legal perspective, the exchange of GMP certificates was the preferred option within Europe, consideration should be given to the advantages of an exchange of inspection reports between worldwide competent authorities as it allows to share an essential technical record of the full inspection process and outcome and is for the receiving party an essential source of relevant information for its risk management process.
Conclusion: the exchange between authorities of inspection reports and use of the information they contain for the planning of next inspections increase the number of inspections performed of value to more than one authority. It was difficult to accurately assess an overall increase in the number of sites inspected; information on whether participants increased or decreased their inspectional resources during the pilot for reasons not related to the programme was not available. From the feed back given by the participants it appears that the sharing of inspectional information, in combination with the impact of joint inspections led to confidence building and to the firsthand knowledge that either the inspections performed by the participants were comparable, or that differences were understood.
Although a small number of joint inspections were performed during the pilot, helping to build confidence, the number was limited because of the additional work and time needed to organize them. As a result, work sharing was not always accompanied by the possibility to reallocate resources. In addition, the need expressed by inspectors in the feed back forms to meet before a joint inspection to prepare and afterwards to discuss outcomes contributed to the reduction of efficiencies.
Conclusion: based on the experience to-date, it is expected that more efficient and consistent organization of joint inspections , combined with timely sharing of information on past and planned inspections should lead in the future to the possibility to free up inspectional resources and thus improve inspection coverage. The exercise was found to be very positive by all the participants and a good step forward for information exchange and confidence building between authorities in an informal and efficient manner.
It also allowed the participants to examine and assess their internal processes in comparison to those of the partner agencies and to promote best practices towards better collaboration.
The reliance on other equivalent regulatory authorities was found to be a major asset for participants although some aspects of the cooperation were found to be logistically more complex than anticipated. The excel spreadsheet used for the Master List was found to be suitable for the compilation of retrospective and prospective inspection data at the initial stages of the project.
However, as was pointed out during several teleconferences, the exchange was not fully satisfactory as it was dependent on regular forwarding of information from the participants to EMA, update of the Master List by EMA and then distribution to all participants of the updated Master list by the EMA. It would be preferable to identify a secure host for a simple database, which enables the agencies to record and share data in real-time.
A closely related issue is the need to better standardize the identification and nomenclature of sites and manufacturing processes to avoid misunderstandings especially with a view to the planning of joint inspections.
Coordination of the pilot programme which was done by the EMA was found to be essential, although it was a major resource cost. In addition organization of periodic teleconferences was found to be of high importance for overall cooperation and program coordination although the key information was exchanged by e-mails.
The location of the participants in different time zones was an additional difficulty. Recommendation: A common, live data source posted on a secure web page with timely updates by all participants would reduce some of the coordination efforts although some management will always be required. Project metrics were clearly defined and agreed upon in order to establish reporting.
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The project metrics included the number of requested and received inspection reports, joint inspections, extended scope reports and inspection outcomes. Recording of metrics were managed by the EMA for all participants and centralised in the Master List. Counts often were not entirely in agreement due to the definition of 'request' versus 'completed request', timeframe of counts, which firms were part of the pilot, as well as by type of information full report versus inspection outcome summary for example.
Several logistical time challenges were met when the Pilot started. Specific contact persons and dedicated electronic mailboxes had to be identified and created in order to avoid delays in receiving requests and in sending reports. Some agencies' laws and regulations mandated redaction of these reports, which added delays to the overall exchange process. This was especially true when 'batches' of 10 or more reports were requested all at once. However, noticeable improvements were achieved by the end of the Pilot when participants had streamlined their own internal processes for the benefit of all participants.
Although joint inspections were not originally intended to be a major focus of the pilot, a number of joint inspections did take place. In addition a couple of joint inspections had to be cancelled due to the absence of effective advance planning and logistical issues. For all participants, planning has to begin very far in advance because available inspectors need to be identified early to enable pre-inspection planning, logistics etc to be undertaken.
Inspection dates had to be found when inspectors of two participating authorities were available and when no restrictions on the possible inspection dates occurred due to specific public holidays or festivals typical in Asian countries. A number of 'duplicate' inspections were identified, reflecting either inspections were inadequate to meet the needs of other parties, or lost opportunities for work sharing.
Automatic Exchange of Information
Recommendation; Planning of joint inspections should commence as early as possible and include the identification of the inspectors, so that the contact between the future inspection team can be established at the earliest stage possible. This could be further extended to include agreement to manage the inspection close-out by one agency on behalf of all participants noting each agency would continue to have prerogative to determine any subsequent regulatory action. However, most participants have constraints that may limit from moving forward with this proposal, specifically, if the joint inspection report requires a modification to the existing format and structure.
Recommendation: As an interim measure a joint inspection report format and basis for content should be developed, so as to standardize what is used and understood in terms of coverage. The feedback forms were considered to provide meaningful contribution to the evaluation of a joint inspection and to identify differentials between the participants.
Feedback is critical to ensure a posteriori that the parties were able to inspect together using equivalent inspection procedures and GMP interpretations. One of the main information reported repeatedly on the forms was the usefulness of a pre and post inspection meeting of the inspection team to prepare and conclude optimally the inspection.