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Management Response and Action Plan (MRAP) - Audit of the Use of the Standards-Based Approach in Regulations - Biologics and Genetic Therapies Directorate

September 2009

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Biologics and Genetic Therapies Directorate (BGTD)
Recommendations	Management Response: 1. Accept 2. Accept with conditions 3. Reject	Planned Management Actions	Deliverables	Expected Completion Date	Accountability
Recommendation: It is recommended that the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) further strengthen its policy development process as it relates to managing complex projects for use of the standards-based approach, including the requirements to: systematically profile risks develop action plans with reasonable timelines formalize change management action; and routinely report on results.	HPFB Management accepts the recommendation		NIHB will continue to review reports on distribution of User Manual Updates to ensure the information is available for relevant users.
	The Health Products and Food Branch acknowledges that complex regulatory projects present special challenges and that processes must be in place to manage these projects such that continued progress is made and the objectives of the project remain relevant as time on the project elapses. In the time since the standards-based regulatory framework projects for Blood and Cells, Tissues and Organs were initiated in the mid-1990s, numerous new tools and provisions to support the regulatory process have been implemented, many of which address this recommendation.		HPFB will complement these tools with additional action as described under Deliverables
		Update Lessons Learned	Update and share internal report Lessons Learned to Date in Developing a Standards-Based Approach to the Regulation of Cells Tissues and Organs for Transplantation and Blood and Blood Components for Transfusion with other HPFB Directorates via the LRM-SC;	October 31, 2009	Biologics and Genetic Therapies Directorate (BGTD)
		Issues Analysis	Complete Issue Analysis Summary to determine the need to reform the Departmental Standards Committee.	September 30, 2009	BGTD lead for approval of recommendation by Legislative Regulatory Modernization Steering Committee (LRM - SC)
	Specifically, the creation of the Policy, Planning and International Affairs Directorate whose mandate is to provide leadership in developing and advancing HPFB's agenda as well as the creation of a Legislative and Regulatory Modernization Steering Committee. This committee steers HPFB's work to modernize the Food and Drugs Act	Policy Review	Review existing policy and regulatory development guidance, to ensure that adequate and up to date information about experience with Standards Based Approach (SBA) is included within each;	October 15, 2009	BGTD to review common policy development documents and present to LRM-SC
		Stakeholder Sharing	Enhance initiatives to directly share branch experiences with use of SBA with other branches and departments via: collaboration with CSA on training/ information sessions for regulators considering use of SBA;	Ongoing	BGTD
			ensuring that practical information on the use of SBA is incorporated into training given by the Office of Continuing Education in its ongoing course Introduction to the Regulatory Process;	September 30, 2009	BGTD
			collaborate with the Canadian School of Public Service to ensure that information on the use of SBA continues to be included and profiled in its regulatory training courses.	September 30, 2009	BGTD
		Develop Criteria	Develop criteria for determining when a regulatory project qualifies as complex, necessitating special oversight by LRM-SC and direct leadership by OLRM,	January 2010	BGTD/ Policy, Planning and International Affairs Directorate (PPIAD) in collaboration with directorates
		Standard Operating Procedures	Develop standard operating procedure for the management of a complex regulatory project will be developed.	January 2010	BGTD/PPIAD in collaboration with directorates
		Progress Reporting	Progress report to ADMO on progress implementing this response	January 2010	BGTD/PPIAD