Record of decisions - Nuclear Medicine Alliance (NMA) and the Biologics and Genetic Therapies Directorate (BGTD) bilateral meeting - April 3, 2012

Tuesday, April 3, 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)
• Agnes Klein, CERB, BGTD
• Georgette Roy, ORA, BGTD
• Christopher Antonio, ORA, BGTD
• Jian Wang, CERB, BGTD
• Stephanie Reid, GMPU, HPFBI
• Nicholas Shipley, ELBIU, HPFBI
• Scott McCash, OPIC, BGTD

Regrets

• Robert Cushman, BGTD, HPFB

Nuclear Medicine Alliance (NMA) participants

• Jessica Duval - Covidien
• Tim Nason - Lantheus
• Guy Cimon - Siemens
• Ann Warbick - Independent
• Charles Vachon - Jubilant Draximage
• Marie-Pierre Ekoka - Jubilant Draximage
• Christopher Leon - CPDC

Teleconference

• Maarten Billen, MEDEC
• Clotilde Palermo - GE
• Len Ducker - GE
• Doug Abrams - Alberta Health

1.0 Welcome and introductions

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

2.0 Review of agenda

The agenda for the meeting as well as the final meeting report from a facilitated session held between the two organizations on January 17, 2012 were approved.

3.0 Review of NMA-BGTD facilitated session

On January 17, 2012, BGTD and the NMA met for a facilitated session to review the effectiveness of the organizations' bilateral meeting program and to agree what needs to be done to set it up for future success. Some of the key messages resulting from this session included:

• Both parties felt the meetings were worthwhile and recommitted to bilateral meetings continuing.
• The importance of investing time up-front in agenda development and meeting preparation was highlighted to ensure the success of the meeting.
• It may be useful to establish a regular schedule for bilateral meetings (e.g. every last Tuesday of the month).
• Health Canada initiatives (whether they originate from BGTD or any of the other groups) will be brought to NMA's attention in a timely manner.
• There is a need for higher-level communication so both parties are aware of what is happening in both organizations.
• Compliance and enforcement issues, issues related to performance and updates regarding international harmonization should be standing items on the agenda.
• A more formalized process for meetings will help make meetings more useful for all and help participation from both sides.

4.0 Standing items

A. International update

C. Parker informed the group that BGTD performs a weekly policy scan of international regulators. In the past the focus of this scan has been on issues related to biologics, but in response to the commitment to make updates on international issues a standing agenda item, BGTD has changed its process to develop stronger focus on radiopharmaceuticals. BGTD will perform this weekly scan and will present the results at bilateral meetings moving forward. If a scan reveals an issue that BGTD feels the NMA should be aware of sooner than the next scheduled bilateral meeting, it will communicate this issue via MEDEC.

B. Regulatory performance update

In response to a question from A. Warbick, G. Roy clarified that BGTD Annual and Quarterly Drug Submission Performance Reports do not present performance data by product line. However, as regulatory performance is now a standing item on the agenda, performance data specific to radiopharmaceuticals will be presented at each bilateral meeting.

G. Roy informed the NMA that a total of 16 authorizations had been made for radiopharmaceutical products between January 1, 2012 and April 3, 2012 and provided a breakdown by authorization type. Each of the 16 decisions was made within the performance target.

Action item:

In response to requests from A. Warbick and T. Nason, future regulatory performance updates will include a breakdown of decisions by percentage of positron-emitting radiopharmaceuticals (PERs) vs. non-PERs and the total number of days to decision.

C. Compliance and enforcement update

S. Reid provided information on a number of guidance documents currently being updated that may impact radiopharmaceuticals. This update was given in response to the request that emerged from the facilitated session that a compliance and enforcement update becomes a standing agenda item.

Both the Cleaning Validation Guideline (GUI-0028) and the Process Validation: Terminal Sterilization Process for Pharmaceutical Products Guideline (GUI-0074) have been revised and consultation on both guidance documents started in December 2011. In total, several hundred comments were received from multiple stakeholders. S. Reid stated that it is currently the intention of the Health Products and Food Branch Inspectorate to review the comments and to have new versions of each document finalized by the end of the current fiscal year.

S. Reid also indicated that the Annex to Good Manufacturing Practices (GMP) Guidelines for Positron Emitting Radiopharmaceuticals (PERs) (GUI-0071) will soon be revised as part of the Inspectorate's program quality management process and that, should changes be considered extensive or significant, public consultation would happen in 2012.

5.0 Health Canada initiatives affecting Schedule C Drugs

A. Warbick asked that Health Canada update the NMA on efforts that have been taken to ensure that the radiopharmaceutical industry is being included in all Health Canada consultations, including those which take place on a broader level than BGTD only.

C. Parker indicated that BGTD has taken steps to ensure that appropriate representatives of the radiopharmaceutical sector are included in all HPFB consultations. The Stakeholder Information Management System has recently been updated to include main contacts in all of the radiopharmaceutical-linked associations. This will ensure that any consultations by mail include these associations. Furthermore, BGTD is in the process of assembling a complete list of associations for use by the Department's Office of Consumer and Public Involvement in their master list of associations for consultation.

BGTD will provide regular updates to NMA on upcoming consultations, in order to determine in advance the NMA's interest in participating.

6.0 Request for a regulatory opinion

A. Warbick requested that BGTD provide the NMA with a regulatory opinion on the continued provision of a radiopharmaceutical under a Clinical Trial Application (CTA) when an NOC has been granted based on an NDS that is supported with data obtained under the CTA.

C. Parker responded that all CTAs are carefully reviewed to make sure that clinical trials are genuine and not merely attempts to bypass the market authorization process. A. Klein clarified that due to their short half-life, PERs are dealt with on a regional basis.

L. Ducker asked whether it is Health Canada policy to expedite the review of submissions for PERs that are available in one region of the country but not another. A. Klein confirmed that, since that situation would constitute a shortage, this would be the case.

7.0 Regulation of Active Pharmaceutical Ingredients

A. Warbick requested that the NMA be provided with information pertaining to plans to regulate Active Pharmaceutical Ingredients (APIs), including the inspection of facilities that manufacture APIs, and the impact that these plans would have on the radiopharmaceutical industry.

S. Reid responded that Health Canada has been working on the development of a regulatory framework for APIs and currently does not have any plans to modify GMP requirements for radiopharmaceuticals which contain drugs of biological origin. Radiopharmaceuticals containing pharmaceutical drugs will be expected to comply with the new requirements for APIs proposed in the regulatory amendment.

8.0 Implementation of Drug Identification Numbers for Schedule C Drugs

A. Warbick asked for an update on the implementation of Drug Identification Number (DIN) requirements for radiopharmaceuticals. C. Parker responded that the DIN regulatory amendment has not yet been finalized and that a Canada Gazette I publication is targeted for Fall 2012. This provides Health Canada and the radiopharmaceutical sector sufficient time to operationalize the DIN requirement process. BGTD commits to work with stakeholders on an implementation plan.

9.0 BGTD Regulatory workshop on Radiopharmaceuticals

C. Parker provided a summary of BGTD's Regulatory Workshop on Radiopharmaceuticals held in March 2012. The Workshop was held to provide stakeholders with a deeper understanding of Health Canada's regulatory oversight of radiopharmaceuticals and to facilitate open dialogue between the regulator and its stakeholders. The Workshop was well attended and well received.

Action item:

BGTD is asked to provide an update on the frequency of these Workshops moving forward.

10.0 Roundtable

T. Nason requested an update on generic radiopharmaceuticals. A Klein responded that Health Canada guidance is currently being developed and that it will be posted for comment and feedback once the draft guidance is complete.

Action item:

BGTD is asked to include an update on generic radiopharmaceuticals on the agenda for the next bilateral meeting.

The meeting was adjourned at 3:30pm.