Record of decisions - Nuclear Medicine Alliance (NMA) and the Biologics and Genetic Therapies Directorate (BGTD) bilateral meeting - September 25, 2012

Tuesday, September 25, 2012
1:00 pm to 3:30 pm
200 Tunney's Pasture Driveway, Room 0105, Tunney's Pasture, Ottawa, ON

Attendance

Health Canada participants

Catherine Parker, OPIC, BGTD (Chair)
Georgette Roy, ORA, BGTD
Christopher Antonio, ORA, BGTD
Jian Wang, CERB, BGTD
Rezaul Mannan, CERB, BGTD
Anthony Ridgway, CERB, BGTD
Michel Trottier, SEIB, MHPD
Paul Gustafson, GMPU, HPFBI
Scott McCash, OPIC, BGTD

Regrets

Robert Cushman, BGTD, HPFB

Nuclear Medicine Alliance (NMA) participants

Maarten Billen - MEDEC
Clotilde Palermo - GE
Tim Nason - Lantheus
Ann Goodbody - Imaging Probes
Christopher Leon - Imaging Probes
John Korontzis - Covidien
Jessica Duval - Covidien

1.0 Welcome and introductions

C. Parker, Director for OPIC, BGTD, co-chaired the meeting in the absence of Dr. Robert Cushman, Director General of BGTD. C. Parker welcomed everyone and after round table introductions, gave opening remarks.

T. Nason acted as co-chair and gave opening remarks including the announcement that former co-chair A. Warbick has retired.

2.0 Review of agenda

The agenda for the meeting was approved.

3.0 Standing items

A. Regulatory performance update

G. Roy informed the NMA that a total of 34 decisions had been made for radiopharmaceutical products between April 1, 2012 and August 31, 2012 and provided a breakdown by authorization type. Each of the 34 decisions was made within the performance target. It was further noted that no generic radiopharmaceuticals were authorized during this period and that only one of the authorizations made was a PER product. G. Roy asked the NMA whether the level of information was useful for their purposes and noted that the information provided at the bilateral meetings could be further tailored to meet the needs of NMA participants.

T. Nason indicated that the NMA will be conducting a debriefing following the meeting and that any further suggestions would be passed along following that meeting.

B. International update

C. Parker noted the challenge of developing international information-sharing partnerships for radiopharmaceuticals and explained that BGTD performs a weekly policy scan of international regulators in an effort to identify issues related to the nuclear medicine industry. Issues that are identified as being relevant to the NMA will be flagged for their consideration at future bilateral meetings or, if the issue is more pressing, communicated to MEDEC directly.

C. Parker also asked for feedback on the Annex to the supporting document which was provided, including whether the information provided was timely enough to be useful and whether the NMA had suggestions to enhance BGTD's international regulatory monitoring.

T. Nason indicated that this is another issue that the NMA will review during the debriefing and provide BGTD with comments following that meeting.

C. Compliance and Enforcement update

P. Gustafson provided an update on a number of guidance documents currently being updated that have relevance to the nuclear medicine industry.

Both the Cleaning Validation Guideline (GUI-0028) and the Process Validation: Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074) are currently being updated following a consultation process and are expected to become effective by the end of fiscal year 2012-2013.

Revisions to the Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs) (GUI-0071) will be discussed at the GMP Committee meeting September 25-27, 2012. Should the changes be considered extensive or significant, this Annex is expected to go for public consultation in late 2012 or early 2013.

J. Duval asked for an update with respect to GMP regulations for API as members are interested in being involved in the development of GMP expectations for API. P. Gustafson expressed that processes are currently underway relating to these regulations and as a result further information can be disclosed only after posting regulations in Canada Gazette. It was proposed that further details be deferred to a future bilateral meeting.

A. Goodbody asked for clarification on the revisions to the Good Manufacturing Practices (GMPs) for PERs, specifically what the drivers for change are. P. Gustafson replied that, based on observations that inspectors have been making, it has become evident that clarification around Health Canada's expectations may be required.

C. Leon asked whether there has been any thought around the idea of providing inspection report findings and information from one site to another. Recognising that confidential information would need to remain so, it was noted that communicating this information across the nuclear medicine industry could be beneficial in helping sites better prepare for inspections. P. Gustafson stated that the Health Products and Food Branch Inspectorate (HPFBI) is always looking for ways to improve openness and transparency. The Inspectorate is currently considering initiatives to increase this transparency. An update on such initiatives may be provided at the next bilateral meeting.

Action items

NMA will propose any changes to the Regulatory Update standing agenda item they would like to see moving forward

NMA will propose ways to enhance BGTD's monitoring of international issues related to nuclear medicine.

HPFBI will present an update on strategies for sharing inspection-related information at the next bilateral meeting.

HPFBI will provide an update on the API regulations at the next bilateral meeting.

4.0 Canada Vigilance and E-Reporting

M. Trottier made a presentation on the Electronic Reporting of Adverse Reactions by Industry and Clinical Trial Sponsors to Canada Vigilance initiative. The presentation outlined the scope of the Canada Vigilance program, the business requirements for electronic reporting (including the different approaches that different sized trading partners might pursue), explained AR reporting and the benefits of reporting electronically and outlined the business rules involved.

M. Trottier reported that the pilot phase of the project has been implemented with several trading partners, with the first pilot having started in July 2012. Phase II of the implementation process involving smaller trading partners is currently in development and is expected to be implemented at the start of next fiscal year.

5.0 Update on Radiopharmaceutical workshops

C. Parker provided an update on radiopharmaceutical workshops, noting that a Q&A document is being developed to address the questions and issues that arose at the workshop held in March 2012. It was noted that there has been a great deal of interest expressed in holding radiopharmaceutical workshops on a regular basis but that BGTD budget constraints will limit the size and location of future workshops.

Following comments from C. Leon and T. Nason indicating that the NMA is content to have the workshops take place in Ottawa, it was decided that moving forward BGTD would organise radiopharmaceutical workshops in Ottawa biannually, with the next workshop occurring in fall 2013.

Following a recommendation from A. Goodbody to better leverage the Society for Nuclear Medicine (SNM) annual meetings, C. Parker indicated that BGTD would coordinate a satellite session consisting of 2-3 BGTD representatives at the next SNM meeting.

Action item

BGTD will convene a radiopharmaceutical workshop Working Group and put out a call for industry participation to coordinate the fall 2013 workshop.

6.0 Generic Radiopharmaceuticals

C. Parker presented an update on generic radiopharmaceuticals, noting that a BGTD Working Group has been working on a guidance document: Information and Submission Requirements for Schedule C Drugs whose purpose is to provide sponsors of Schedule C drugs with the information and regulatory requirements necessary to satisfy C.08.002 (2) and C.08002.1 of the Food and Drug Regulations for New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS). Significant progress has been made on the requirements for the ANDS pathway for radiopharmaceuticals that can be approved using the abbreviated new drug submission pathway. External consultation on the guidance document is expected in 2013.

T. Nason expressed concern that Health Canada's approval of generic radiopharmaceuticals has the potential to have a great impact on the nuclear medicine industry, especially given the lack of patent protection for many products. It was explained that there will be a shift in the way that companies make business decisions in a new 'generic' environment.

C. Parker recognised the concern, noting that policy development on this issue has evolved with the science. C. Parker suggested that in the interest of openness and transparency, BGTD will develop an interim communication in the form of a written Notice to Stakeholders to provide industry with an outline of the regulatory proposal and an early opportunity to provide comments.

Action item

BGTD will develop a Notice to Stakeholders for the guidance document: Information and Submission Requirements for Schedule C Drugs to be published in 2012.

7.0 DINs for Radiopharmaceuticals

C. Palermo asked for an update on the implementation of Drug Identification Number (DIN) requirements for radiopharmaceuticals. C. Parker responded that a Canada Gazette I publication is targeted for spring 2013, with a 75-day comment period to follow. Final regulations will come into effect six months after CG II publication which is targeted for fall 2013. Coming into force would initiate the beginning of a 6-month transitional period, meaning manufacturers can continue to sell product provided paper to have DINs issued was filed by the end of the 6-month period. HPFB would be targeting the issuance of DINs for all marketed products by mid- to late-2015.

C. Parker noted that an implementation plan will be developed in collaboration with industry.

T. Nason indicated that a call for membership on this WG would be put out at the debriefing meeting.

C. Leon questioned how products with different ranges of activities will be handled under the DIN scheme, noting that this is a significant concern for industry. Although the approach has yet to be decided, C. Parker stated that this concern is acknowledged and that BGTD will strive to develop a solution that minimizes the impact on companies.

Action item

NMA will nominate representatives for a BGTD-led Working Group to develop an implementation plan for the DINs for Radiopharmaceuticals initiative.

8.0 Roundtable

C. Parker noted that the Plain Language Labelling regulatory initiative is a Branch priority and that the NMA should be aware of this initiative and be prepared to comment when the consultation process begins, likely in 2013.

C. Palermo inquired about the status of an update to the BGTD post-NOC guidance document. A Ridgway responded that an update is planned in the future.

Action item

BGTD will ask a representative from the Office of Regulatory and Legislative Modernisation to present an update on this project at the next bilateral meeting.

The meeting was adjourned at 3:00pm