File Ref.: FHB/H/23/4 LEGISLATIVE COUNCIL BRIEF Pharmacy and Poisons Ordinance (Cap 138) PHARMACY AND POISONS (AMENDMENT) (NO. 7) REGULATION 2015 INTRODUCTION The Pharmacy and Poisons Regulations (Cap. 138A) ( the Regulations ) was made under section 29 of the Pharmacy and Poisons Ordinance (Cap. 138) ( the Ordinance ). The Pharmacy and Poisons (Amendment) (No. 7) Regulation 2015 ( the Amendment Regulation ) at Annex A is to amend Schedules 1, 3 and 10 to the Regulations. JUSTIFICATIONS General Background 2. Under section 29(1B) of the Ordinance, the Pharmacy and Poisons Board ( the Board ) set up under section 3 of the Ordinance is empowered to make regulations to amend the Poisons List; or any list of articles or substances in the Regulations, subject to section 31 of the Ordinance and to the approval of the Secretary for Food and Health. Proposal of the Pharmacy and Poisons Board 3. Having considered an application for re-classification of Clotrimazole; its salts when contained in pharmaceutical products labelled only for the treatment of tinea pedis or tinea cruris, or both, the Board recommends amending Division A of Part 1 and Division A of Part 2 of Schedule 10 to the Regulations. The proposed amendment aims to relax the control of Clotrimazole; its salts when contained in pharmaceutical products labelled only for the treatment of tinea pedis or tinea cruris, or both, by re-classifying them from Part 1 poisons to Part 2 poisons.
4. Moreover, arising from applications for registration of seven pharmaceutical products, the Board proposes to add the following substances to Division A of Schedule 1, Division A of Schedule 3 and Division A of Part 1 of the Poisons List set out in Schedule 10 to the Regulations. (a) Ceritinib; its salts (b) Dulaglutide (c) Nivolumab (d) Pembrolizumab (e) Pirfenidone; its salts (f) Pyriprole; its salts (g) Secukinumab 5. Details of the above substances are set out at Annex B. The Board considers the proposed amendments appropriate in view of the potency, toxicity and potential side effects of the substances. THE AMENDMENT REGULATION 6. The Amendment Regulation is to re-classify the substance under the conditions listed in paragraph 3 above from Part 1 to Part 2 of Schedule 10 to the Regulations and to add the substances listed in paragraph 4 above to the relevant Schedules to the Regulations. LEGISLATIVE TIMETABLE 6. The legislative timetable will be Publication in the Gazette 11 December 2015 Date of Commencement 11 December 2015 IMPLICATIONS OF THE PROPOSAL 7. The proposal will impose appropriate control on pharmaceutical 2
products consisting of the above substances so that they can be sold in the market upon fulfillment of the relevant regulations. ENQUIRY 8. For any enquiries on the brief, please contact Mr Chow Tat-wing, Assistant Secretary for Food and Health, at 3509 8956. Food and Health Bureau December 2015 3
附 件 A Annex A
附 件 B Annex B Pharmacy and Poisons (Amendment) (No. 7) Regulation 2015 Supplementary Information to the Legislative Council 2015 年 藥 劑 業 及 毒 藥 ( 修 訂 )( 第 7 號 ) 規 例 提 交 立 法 會 的 補 充 資 料 Drug Name 藥 名 Ceritinib; its salts Proposed Classification 建 議 類 別 Reasons 原 因 This drug is used for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer previously treated with crizotinib (ALK inhibitor). 塞 瑞 替 尼 ; 其 鹽 類 Side effects include anaemia, decreased appetite, diarrhoea, nausea, vomiting, abdominal pain, constipation, rash and fatigue. 此 藥 物 用 於 治 療 曾 經 接 受 克 唑 替 尼 ( 間 變 性 淋 巴 瘤 激 酶 (ALK) 的 抑 製 劑 ) 療 程,ALK 呈 陽 性 晚 期 非 小 細 胞 肺 癌 的 成 年 患 者 副 作 用 包 括 貧 血 食 慾 下 降 腹 瀉 噁 心 嘔 吐 腹 痛 便 秘 皮 疹 和 疲 勞 Page 1
Dulaglutide This drug is used in adults with type 2 diabetes mellitus to improve glycaemic control as monotherapy, or add-on therapy in combination with other glucose-lowering medicinal products including insulin. Side effects include hypoglycaemia, nausea, diarrhoea, vomiting and abdominal pain. Dulaglutide ( 註 : 暫 無 中 文 名 稱 ) 此 藥 物 可 作 為 單 獨 療 法, 或 綜 合 其 他 降 糖 藥 物 包 括 胰 島 素 的 附 加 療 法, 應 用 於 糖 尿 病 二 型 的 成 年 患 者, 改 善 其 血 糖 控 制 副 作 用 包 括 低 血 糖 噁 心 腹 瀉 嘔 吐 和 腹 痛 Page 2
Nivolumab This drug is used for the treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor; and adult patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. 尼 伏 人 單 抗 Side effects include rash, fatigue, dyspnea, cough, musculoskeletal pain, decreased appetite, nausea and constipation. 此 藥 物 用 於 治 療 不 能 切 除 或 轉 移 性 黑 色 素 瘤, 經 伊 匹 木 單 抗 治 療 後, 及 如 BRAF V600 突 變 呈 陽 性, 經 BRAF 抑 製 劑 治 療 後, 病 情 仍 惡 化 的 成 年 患 者 ; 亦 可 用 於 治 療 轉 移 性 鱗 狀 非 小 細 胞 肺 癌, 經 鉑 為 基 礎 的 化 療 後, 病 情 仍 惡 化 的 成 年 患 者 副 作 用 包 括 皮 疹 疲 勞 呼 吸 困 難 咳 嗽 肌 肉 骨 骼 疼 痛 食 慾 下 降 噁 心 和 便 秘 Page 3
Pembrolizumab This drug is used for the treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. 匹 博 利 組 單 抗 Side effects include fatigue, cough, nausea, rash, decreased appetite, constipation, arthralgia and diarrhoea. 此 藥 物 用 於 治 療 不 能 切 除 或 轉 移 性 黑 色 素 瘤, 經 伊 匹 木 單 抗 治 療 後, 及 如 BRAF V600 突 變 呈 陽 性, 經 BRAF 抑 製 劑 治 療 後, 病 情 仍 惡 化 的 成 年 患 者 副 作 用 包 括 疲 勞 咳 嗽 噁 心 皮 疹 食 慾 下 降 便 秘 關 節 痛 和 腹 瀉 Pirfenidone; its salts This drug is used in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis. Side effects include anorexia, dyspepsia, nausea, diarrhoea, photosensitivity, rash and fatigue. 吡 非 尼 酮 ; 其 鹽 類 此 藥 物 用 於 治 療 輕 至 中 度 特 發 性 肺 部 纖 維 化 的 成 年 患 者 副 作 用 包 括 食 慾 不 振 消 化 不 良 噁 心 腹 瀉 光 綫 敏 感 皮 疹 和 疲 勞 Page 4
Pyriprole; its salts This drug is used for the treatment and prevention of flea and tick infestations in dogs. Side effects include pruritus, lethargy and emesis. Pyriprole; 其 鹽 類 ( 註 :Pyriprole 暫 無 中 文 名 稱 ) Its use should be decided by a veterinary surgeon based on the animal s conditions. 此 藥 物 用 於 治 療 和 預 防 狗 隻 受 到 跳 蚤 和 蜱 的 侵 擾 副 作 用 包 括 瘙 癢 嗜 睡 和 嘔 吐 使 用 此 藥 物 與 否, 須 由 獸 醫 按 動 物 的 情 況 決 定 Secukinumab This drug is used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Side effects include upper respiratory tract infection, oral herpes and diarrhoea. Secukinumab ( 註 : 暫 無 中 文 名 稱 ) 此 藥 用 於 治 療 適 合 接 受 全 身 系 統 性 療 程, 中 度 至 嚴 重 程 度 斑 塊 型 銀 屑 病 的 成 年 患 者 副 作 用 包 括 上 呼 吸 道 感 染 口 腔 皰 疹 和 腹 瀉 Page 5