Record of Decisions Nuclear Medicine Alliance and the Biologics and Genetic Therapies Directorate (BGTD)

Monday, June 20, 2011
1:30 pm to 3:30 pm
200 Tunney's Pasture Driveway, Room 0105, Tunney's Pasture, Ottawa, ON

Attendance:

Present

• Catherine Parker, OPIC, BGTD (Co-Chair)
• Julie Gervais, OPIC, BGTD
• Barbara Wong, OPIC, BGTD
• Andrea Bedard, OPIC BGTD
• Anthony Ridgway, CERB, BGTD
• Georgette Roy, ORA, BGTD
• Christopher Antonio, ORA, BGTD
• Fern Levine, CERB, BGTD
• Rod Huggins, CERB, BGTD

Regrets

• Agnes V. Klein, BGTD, HPFB

Nuclear Medicine Alliance

• Stephen Dibert - MEDEC (Co-Chair)
• Andre Gagnon - Pharmalogic Services TEP de Montreal
• Jessica Duval, Covidien
• Charles Vachon, Draxis
• Chris Leon, Centre for Probe Development and Commercialization
• Anne Goodbody, Centre for Probe Development and Commercialization
• Ann Warbick, MDS Nordion
• Tim Nason, Lantheus Medical Imaging Canada

Teleconference

• Dr. Jean-Luc Urbain, Canadian Association of Nuclear Medicine
• Maarten Billen, MEDEC

1.0 Welcome and Introductions

The Co-Chairs welcomed everyone and after round table introductions, the Co-chairs gave opening remarks.

Cathy Parker, Director for OPIC, BGTD, co-chaired the meeting in the absence of Dr. Agnes V. Klein, Director of CERB.

2.0 Follow up items arising from previous meetings: Summary of Radiopharmaceuticals approved in Canada; Standardization of inspections

The agenda for the meeting, as well as the minutes of the previous meeting held December 15, 2010, were approved. As the Inspectorate could not make it to the meeting, any questions regarding the standardization of inspections could be requested and the answer would be provided at a later date. NMA members stated that they would like a list of radiopharmaceuticals approved in Canada. C. Parker and G. Roy explained the difficulties Health Canada encounters in tracking the market status of radiopharmaceuticals since they currently do not have DINs (see notes for item 3). It was agreed that BGTD would provide at each bilateral meeting an update on what new products had recently been approved.

3.0 Regulatory Amendment Respecting DINs for Radiopharmaceuticals

J. Gervais presented a slide deck on a proposal for a regulatory amendment to require radiopharmaceuticals to be assigned Drug Identification Numbers (DINs). As DINs are currently used to track market authorization status of drug products without DINs, Health Canada currently has no mechanism for tracking the market status of radiopharmaceuticals. Their exemption from the DIN requirement hinders regulator, industry and health care practitioner access to accurate and timely information on product availability. This exemption also creates an imbalance in regulatory approach between radiopharmaceuticals and other drugs. Hence, BGTD will be proposing a regulatory amendment to remove the exemption from DIN requirements and replace the current EL number with the DIN on the labels for radiopharmaceutical products. A Notice of Intent was published in Canada Gazette, Part I on July 28, 2007. The comments received were supportive of proposed amendments. The target date for publication of the proposed regulatory amendments in Canada Gazette, Part I will be in the Fall of 2011. A 75 day comment period will follow this publication.

J. Duval asked if the radiopharmaceuticals would be added to the list of other drug companies receive as part of their annual notification. F. Levine stated that all products will go for renewal on the list and this is the responsibility of the Submission Information Policy Division of the Therapeutic Products Directorate, which designs, coordinates and oversees the Annual Drug Notification list.

It was indicated that with respect to radiopharmaceuticals, there are scenarios which may need to be addressed, such as for custom filled products, products with approved dose ranges and generators. Specific consultations on these issues will occur as needed.

4.0 Research PERS regulations

B. Wong gave a presentation on the amendments to the Food and Drug Regulations (FDR) regarding Positron Emitting Radiopharmaceuticals (PERs). In accordance with the clinical trial regulations in Part C, Division 5 of the FDR, basic clinical research studies using PERs currently require a Clinical Trial Application (CTA). Requiring a CTA places an undue regulatory burden on researchers in this field and may be impeding basic clinical research involving PERs in Canada. The proposed amendments will introduce specific regulatory requirements for PERs used in basic clinical research studies into Division 3, Part C of the Regulations which will simplify the application process. Sponsors of basic research studies will still be required to comply with Good Clinical Practices and Good Manufacturing Practices and obtain Research Ethics Board approval prior to submission of application. These amendments are anticipated to reduce costs for industry and reduce complexity of the application process. The draft amendments were originally pre-published in Canada Gazette I in 2009 for a 75-day comment period. Members of the NMA wondered if there would be any follow-up to the original feedback provided. The BGTD had previously suggested that they would meet with the group that provided the feedback to discuss the amendments further. NMA stated that they are still very interested in getting together with BGTD to discuss the PERS regulations. An internal PERs Working Group is working to address stakeholder concerns raised after the original pre-publication. Due to the amount of time that has elapsed since the original pre-publication, it is proposed that the amendments will be pre-published again in Canada Gazette, Part I in late 2011 or early 2012 for an additional comment period. A pre-publication comment period will follow. Comments received will be considered prior to finalizing the Regulations. Until the amendments are in place, an interim enforcement policy requires sponsors of basic research studies to keep documents on site but not to submit them unless requested.

5.0 Update on the implementation of Good Laboratory Practices standards in Canada

C. Parker gave a presentation on the Good Laboratory Practices (GLP) guidance document which came into effect in April 2010. Canada is legally bound by international obligations as a member of the Organization for Economic Co-operation and Development (OECD) to implement the Principles of GLP as a requirement for the submission of all non-clinical safety data. The GLP principles require that countries:

1. Establish a national compliance/monitoring program;
2. Designate an authority for monitoring;
3. Require test facilities to issue a self-declaration; and,
4. Recognize the assurance by another Member country that test data have been generated in accordance with the GLP principles.

The guidance document, entitled Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice, outlines the requirements for Canada. Data not generated under the GLP framework will not be considered reliable and will be treated as supplementary information. In 2009, HPFB signed a Memorandum of Understanding (MOU) with the Standards Council of Canada (SCC) recognizing the Council as Canada's Monitoring authority. The SCC openly provides details regarding inspections to Health Canada.

At this time, Health Canada cannot reject a submission at screening based solely on lack of GLP compliance since it is not, at this point in time, part of the regulations. However the submission evaluators will identify GLP compliance issues as part of the review process and sponsors may be asked to provide further evidence to support data integrity.

6.0 Update on Canadian Association of Nuclear Medicine Annual Conference

Dr. Urbain attended the Annual Canadian Association of Nuclear Medicine conference in Niagara Falls. The conference focused on the need for autonomy in the nuclear medicine profession. The content of the conference included select hybrid imaging, cardiac imaging and procedures with radiopharmaceutical isotopes. The conference did not include as many technologists as desired. The conference organizers may embark on internet conferencing in the future. There were no particular complaints about Health Canada's regulatory activities and it was noted that there has been an improvement in Health Canada's efforts to opening communications to the public and addressing their needs. The community is starting to understand that the industry has to consider business cases. The focus has shifted toward PET scanning across Canada. Providers are doing what they can to provide patients with the very best. As the industry evolves, the Special Access Program might see more requests for rare disorders.

7.0 Regulatory Workshop on Radiopharmaceuticals

G. Roy provided a follow up to discussions from the last bilateral meeting regarding the organization of a regulatory workshop. A Working Group with representatives from NMA has been established and several teleconferences have been held. The proposal is for a 2-day workshop to be held in mid-October in Ottawa. A preliminary draft agenda has been developed. The first day will be scientific sessions and the second day will feature presentations by Health Canada on regulatory frameworks and brainstorm sessions. Briefing notes have been prepared for the Assistant Deputy Minister. If approved, Health Canada will start sending out material and contacting international counterparts. The US-FDA has expressed interest in participating. A. Ridgway added that it will be a tight time-frame but Health Canada will endeavour to get information out to everyone hopefully by the end of June. G. Roy stated that another teleconference will be in place shortly to make sure everything is in place.

8.0 Roundtable

C. Parker stated that the new Cost Recovery initiative came into effect on April 1, 2011. Fees have changed and there will be penalties if Health Canada does not meet performance targets. There is not much expectation for change within BGTD as targets have consistently been met for several years. G. Roy added that additional funds were given to hire more staff. There are additional reviewers, regulatory staff and clerks. C. Parker stated that there are requirements for reporting back to Parliament. There must be a full consultation if any changes are made to the fee structure.

C. Parker stated that the Health Products and Food Branch has initiated a regulatory modernization exercise and will be conducting internal consultations with the intent to progress to external consultations in the Fall. The NMA and NMA regulatory sub-group will be consulted in these matters. Part C, Division 3 (Schedule C drugs) of the Food & Drug Regulations is quite outdated and feedback on efforts to modernize these regulations would be appreciated. Other important initiatives for the Branch include the activities of the Red Tape Reduction Commission and the Regulatory Cooperation Commission, via which Canada and the US are examining ways to harmonize regulatory requirements for low risk health products. HPFB is involved in organizing the Drug Information Association which will be held in Ottawa from October 31 to November 3, 2011. The focus will be on regulatory modernization, red tape reduction, and information to patients.

C.Vachon stated that he understands that BGTD and the Inspectorate are separate but member organizations within NMA are still facing issues regarding the timeline of facility inspections by the Inspectorate. This item will be put on the agenda of the next bilateral meeting.

The NMA and NMA regulatory sub-group thanked BGTD for including them in the consultation process and are willing to participate in all of the initiated programs including but not limited to modernization of Part C, Division 3 (Schedule C drugs) of the Food & Drug Regulations, activities of the Red Tape Reduction Commission, and the Regulatory Cooperation.

J. Duval inquired as to whether there are plans to eliminate Notifiable Change (NC) submissions with the new fee structure. C. Parker stated that NCs are not subject to fees. There are no plans to eliminate NCs as a submission type at this time.

The meeting was adjourned at 3:00pm.