http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/actingre-question-eng.php
Active Pharmaceutical Ingredients - Good Manufacturing Practices - Questions and Answers
活性药用成分---GMP问答
Contact Information:
As stated in the Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients - Coming into force on November 8, 2013, Questions and Answers related to Good Manufacturing Practices for active pharmaceutical ingredients (API GMP Q&As) have been created to provide additional guidance regarding inspections and GMPs specific to APIs.
This Q&A list will be updated on a regular basis.
问答清单将定期更新。
Please note that separate Questions & Answers pertaining to the GMP for APIs Pilot Project for Selected Consumer Health Products will be available on the Health Canada website early in 2014.
请注意自2014年初起，加拿大卫生局网站上可以找到“选择的保健产品原料药中试项目GMP”单独问答。
Please note that separate Frequently Asked Questions - Drug Establishment Licensing and Fees have been updated for APIs and are available on the Health Canada website.
请注意加拿大卫生局网站上现在可以找到更新过的单独的原料药“药品组织执照和费用问答”。
Table of contents
General Questions
Good Manufacturing Practices
Importation / Foreign Buildings / Foreign Building Table (referenced in Part B Section 5.1 of FRM-0033
General Questions
1. What is an active ingredient? What is the difference between an active ingredient, an active pharmaceutical ingredient, and a bulk process intermediate?
什么是活性成分？活性成分、活性药用成分和散装工艺中间体之间有什么区别？
Active ingredients are the substances in drugs that are responsible for the beneficial health effects experienced by consumers. The active ingredient in a pharmaceutical drug is called an active pharmaceutical ingredient (API). An example of an API is the acetaminophen contained in a pain relief tablet. The active ingredient in a biological drug is called a bulk process intermediate (BPI). An example of a BPI is the insulin contained in an insulin pen cartridge, for use by diabetics.
活性成分是用于药品中的物质，对使用者提供有益健康的效果。药品中的活性成分被称为活性药物成分（API，即原料药）。原料药的例子是止痛片中含有的扑热息痛。生物药品中的活性成分称为散装工艺中间体（BPI）。BPI的例子是糖尿病患者所用的胰岛素注射笔筒里所含的胰岛素。
2. Why regulate active ingredients? 为什么要对活性成分进行规范？
The quality of active ingredients in a drug has a direct effect on the safety and efficacy of that drug. Poorly manufactured and contaminated active ingredients have been associated with negative health outcomes, including death, in a number of incidents over the past decades. For this reason, most countries around the world are now regulating active ingredients.
药品中活性物质的质量对药品的安全性和有效性具有直接的效应。在不好条件下生的和受污染的活性成分会带来不好的健康后果，包括死亡，在过年数十年中有许多这样的事故。为此，世界上大部分国家现在对活性物质进行了规范。
Regulating active ingredients in Canada will help increase the quality and safety of drugs for consumers, will strengthen the pharmaceutical drug supply system in Canada, and will bring Canada into line with its international regulatory partners.
在加拿大对活性成分进行规范管理将有助于提高患者所用药品的质量和安全性，加强加拿大的药品供应系统，将加拿大带入国际法规伙伴之列。
3. When will the amended Food and Drug Regulations come into effect? 修订后的食品和药品法什么 时候生效？
The Food and Drug Regulations (Regulations) were amended by extending the requirements of Establishment Licensing and Good Manufacturing Practices to the manufacturing and importation of active pharmaceutical ingredients. The amended Regulations were published in part II of the Canada Gazette on May 8, 2013, and came into force on November 8, 2013.
食品和药品法进行了修订，将对组织执照和GMP的要求延伸到了原料药的生产和进口。修订后的法规已于2013年在加拿大通讯第二部分中公布，将于2013年11月8日生效。
As of November 8, 2013, all establishments in Canada that are conducting the licensable activities of fabrication, packaging/labelling, testing and importing of APIs, including finished dosage form fabricators that import APIs for use in manufacturing their own products, are subject to the applicable GMP requirements and are required to submit an Establishment Licence (EL) application form (FRM-0033), and if applicable, signing the attestation to the GMP compliance status of the foreign buildings where fabrication, packaging/labelling and/or testing of APIs occur (Part B, section 5.1 of FRM-0033) and completing the Foreign Building Information Table referenced in Part B Section 5.1 of FRM-0033 before February 08, 2014.
自2013年11月8日起，所有加拿大境内从事原料药生产、包装/标签、检测和进口持证许可活动的组织，包括进口原料药用于其自己产品生产的制剂生产商，均应符合GMP要求，必须提交组织许可申请表（FRM-0033），如适用，应为国外生产、包装/标签和/或检测原料药的场所签发GMP符合性状态的证明书（B部分，FRM-0033的第5.1部分），在2014年2月8日 前完成第5.1部分第B部分的国外场所信息表。
Importers of finished dosage forms (who are not conducting any API activities in Canada) are subject to the applicable GMP requirements and are required to submit an amendment to their existing EL by signing the attestation to the GMP compliance status of the foreign buildings where fabrication, packaging/labelling and/or testing of APIs occur (Part B, section 5.1 of FRM-0033) and completing the Foreign Building Information Table referenced in Part B Section 5.1 of FRM-0033 to Health Canada before February 8, 2014.
制剂的进口商（在加拿大境内不进行任何原料药活动）应符合GMP要求，应提交其已有EL的增补信息，即签署生产、包装/标签和/或检测原料药的国外场所的GMP符合性状态的证明书（B部分，FRM-0033的第5.1部分），在2014年2月8日 前完成第5.1部分第B部分的国外场所信息表。
Importers of finished dosage forms that also import APIs will be required to submit an EL application to Health Canada in order to include the API importation activity on their EL before February 8, 2014.
同时进口原料药和制剂的进口商要提交一份EL申报给加拿大卫生局，以在2014年2月8日 前将原料药进口活动包括在其EL中。
Distributors and Wholesalers of APIs in Canada that source APIs within Canada and that perform no other licensable activities are subject to the applicable GMP requirements but are not required to hold an EL for these activities.
从事来源于加拿大的原料药的销售和批发的公司，且不进行其它凭许可的活动时，应符合GMP要求，但这些活动不需要持有EL。
Establishments in Canada that begin to conduct licensable activities related to APIs on or after November 8, 2013 are required to:
加拿大境内的组织机构自2013年11月8日起，如需进行与原料药相关的凭许可的活动，则应
o meet the applicable GMP requirements;
o 符合GMP要求
o submit an EL application form (FRM-0033) and, if applicable, the attestation as well as the completed API Foreign Building Information Table;
o 提交一份EL申报表（FRM-0033），适当时，还要提交完整的原料药国外场所信息表
o be inspected and found to be compliant with the applicable Division 2 requirements of the Regulations; and
o 接受检查，且检查结果符合适用的法规第2部分要求
o have a EL issued by Health Canada prior to starting licensable activities.
o 在开始任许可的活动前，持有由加拿大卫生局签发的EL
Finished Dosage Form Fabricators that source APIs within Canada (i.e., do not conduct API licensable activities in Canada) are subject to the applicable GMP requirements but are not required to amend their existing EL. Finished Dosage form fabricator can only use APIs that were fabricated, packaged/labelled and tested by a Canadian or foreign building that met GMP requirements. Furthermore, the finished dosage form fabricator can only source APIs from a Canadian company that meets GMP requirements for importing APIs.
采用来自于加拿大境内的原料药进行生产的制剂生产商（即不在加拿大从事原料药凭许可的活动）需要符合GMP要求，但不需要对其现有EL进行增补。制剂生产商只能使用由符合GMP要求的加拿大和国外场所生产、包装/标签和检测的原料药，制剂生产商只能从加拿大公司采购符合进口原料药GMP要求的原料药。
For additional information please refer to the Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients - Coming into force on November 8, 2013 available on the Health Canada website.
更多住处，参见加拿大卫生局网站上“相关者通知---修订后活性成分食品药品法---自2013年11月8日 起生效”。
4. Do the amended Food and Drug Regulations apply to active ingredients used in pharmaceutical drugs? in biological drugs? in over-the-counter drugs? in veterinary drugs? in natural health products? in disinfectants? 修订后的食品药品法是否适用于药品中使用的活性成分？在生物药品中？在非处方药品中？在兽药中?在天然健康药品中？在消毒剂中？
The decision to modify the Food and Drug Regulations was made after a number of consultations with different industries.
对食品药品法进行修订的决定是在对不同行业进行了大量咨询之后做出的。
The amended Food and Drug Regulations apply to active ingredients in pharmaceutical drugs for human use. Pharmaceutical drugs include both prescription and over-the-counter drugs.
修订后的食品药品法适用于人用药中的活性物质。药品包括处方药和非处方药。
The amended Food and Drug Regulations do not apply to active ingredients used solely in drugs for veterinary use or in natural health products.
修订后的食品药品法不适用于仅用于兽药或自然保健品中的活性成分。
The active ingredients in biological drugs (also known as bulk process intermediates) were subject to the establishment licensing and Good Manufacturing Practices requirements of the Food and Drug Regulationsprior to the amendment which came into force on November 8, 2013. The amended Food and Drug Regulations continue to apply to the active ingredients in biological drugs.
生物药品中的活性成分（也称为BPI）要符合修订前的食品药品法中的组织机构许可要求和GMP要求。修订后的食品药品法对生物制品中的活性成分仍然适用。
Until the new Blood Regulations are made, existing requirements, as they read immediately before the coming into force of the Regulations Amending the Food and Drug Regulations (1475 -- Good Manufacturing Practices), will continue to apply to whole blood and blood components.
在新的血液法规制订前，现有要求仍适用于全血和血液组分。
Active ingredients used in the fabrication of hard surface disinfectants (also known as antimicrobial agents) that are exempt from the requirements of Division 1A (Establishment licences) and Division 2 (Good Manufacturing Practices) of Part C of the Food and Drug Regulations are not covered under the API regulatory framework. Active ingredients used in the manufacture of disinfectant products, which are not considered as antimicrobial agents (such as antiseptic hand soaps), will be covered by the new Regulations.
豁免于食品药品法C部分第1A部分（组织机构许可）和第2部分（GMP）的硬表面消毒剂（也称为抗菌剂）中所用的活性成分不在原料药法规框架内。用于消毒剂产品生产的活性物质，不作为抗菌剂的（如杀菌手用皂），则适用新法。
5. Do the amended Food and Drug Regulations apply to excipients? 修订后的食品药品法是否适用于辅料？
Excipients are drug ingredients other than the active ingredient that produces health benefits for patients. The amendment does not affect the existing requirements for excipients.
辅料是对患者产生健康益处的活性成分以外的药物成分。修订对现有的辅料要求不产生影响。
6. Do the amended Food and Drug Regulations apply to medical gases? 修订后的食品药品法是否适用于药用气体？
The amendment does not affect the existing requirements for medical gases.
修订内容不影响现有的药用气体要求。
7. Will finished dosage form importers be affected by the amended Food and Drug Regulations for active ingredients? 制剂进口商是否受到修订后食品药品法中对活性成分要求的影响？
Finished dosage form importers will be subject to Establishment Licensing and Good Manufacturing Practices (GMP) requirements for the active ingredients used in the finished dosage form drugs they import, and will be required to demonstrate their compliance with the new requirements during their regular inspection. For additional information please refer to the Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients - Coming into force on November 8, 2013 available on the Health Canada website.
制剂进口商进口的制剂中所用的原料药应符合组织机构许可和GMP要求，需要在其常规检查中证明其符合新的要求。更多信息，参见加拿大卫生局网站“相关者通知---修订后活性成分食品药品法---自2013年11月8日起生效”。
加拿大关于进口原料药的新规问答（2/3） 2015-03-07 21:13:27| 分类： 加拿大|
Good Manufacturing Practices
1. What are Good Manufacturing Practices? 什么 是GMP？
Good Manufacturing Practices are a set of internationally recognized standards which are applied to drug manufacturing to ensure drug quality and safety.
GMP是一系列的国际认可的标准，适用于药品生产，用以保证药品质量和安全性。
2. What is the ICH Q7 Guideline? 什么是ICH Q7指南？
The ICH Q7 Guideline is a quality standard that governs the manufacturing of active ingredients. The ICH Q7 Guideline was established by an international organization known as the International Conference on Harmonization, which includes several countries, including the United States, Japan and the countries of the European Union.
ICH Q7 指南是一份管理活性成份生产的质量标准。ICH Q7指南由ICH建立，该组织包括几个国家，其中有美国、日本和欧盟国家。
3. What are the GMP requirements for fabricators, packagers/labellers, testing laboratories, importers, wholesalers and distributors of active ingredients? 原料药生产商、包装商/标签商、化验室、进口商、批发商和分销商的GMP要求是什么？
All Canadian fabricators, packagers/labellers, testing laboratories, importers, wholesalers and distributors of active ingredients must meet Good Manufacturing Practices (GMP) regulatory requirements (Part C, Division 2 of the Food and Drug Regulations). Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) (GUI-0104) is a guide used by companies to understand the requirements and meet Division 2 of the Food and Drug Regulations. This draft guide was available for public consultation in the fall of 2012. The comments received were reviewed and where appropriate, were incorporated into the document. The final version of GUI-0104 was sent via email to stakeholders on December 6, 2013 and will be available on the Health Canada website early in 2014. In the interim, interested stakeholders who wish to obtain this document may send a request for an electronic copy or alternate format of the document to api_questions_ipa@hc-sc.gc.ca
所有加拿大活性成分生产、包装/标签、检测化验室、进口商、批发商和分销商必须符合GMP法规要求（食品药品法第2部分第C部）。活性药用成分（API）的GMP（GUI-0104）是公司用来理解要求和符合食品药品法第2部分的指南。该指南草案从2012年秋天开始公布征求意见。GUI-0104最终版已通过邮件于2013年12月6日发送给相关利益方，2014年早些时候开始在加拿大卫生局网站上可以获得。期间，如果有利益相关方希望得到该文件，可以向上述邮箱发送申报获得该文件的电子备份或其它格式。
4. Which requirements and guideline should I use for the manufacture of an active ingredient sold as finished dosage form (i.e. an API that does not go through any further manufacturing process before being sold)? 我在作为制剂销售的活性成分的生产中应使用哪个要求和指南（即，一种原料药在销售前不需要经过进一步加工处理）？
If the finished product is an active ingredient that is sold as a drug in dosage form, the Good Manufacturing Practices Guidelines, 2009 Edition, Version 2 (GUI-0001) apply.
如果一种活性成分直接以制剂形式销售，则适用GMP指南2009版第2版（GUI-0001）。
All Canadian fabricators, packagers/labellers, testing laboratories, importers, wholesalers and distributors of finished dosage form drugs must meet the Good Manufacturing Practices (GMP) regulatory requirements (Part C, Division 2 of the Food and Drug Regulations). Guidance on the fabrication, packaging/labelling, testing, distribution, wholesaling, and importation of drugs in finished dosage form, is provided in the GUI-0001.
所有加拿大制剂生产商、包装商/标签商、检测化验室、进口商、批发商和分销商必须符合GMP法规要求（食品药品法第2部分第C部）。制剂生产、包装/标签、检测、分销、批发和进口活动的指南包括在GUI-0001中。
5. Does GUI-0104 apply if the API is purchased from a foreign manufacturer then shipped directly to a customer without the product physically being received in Canada even if the purchaser is responsible for the commercial transaction and any quality problems? 如果原料药采购自一个国外生产商，然后直接发给客户而不在加拿大收货，并且采购商负责所有的商业交易和质量问题，是否该原料药适用GUI-0014?
If the purchaser is not conducting a licensable activity, does not take title of the API, and only provides a service, then GUI-0104 does not apply. If the purchaser sells or offers for sale the API and acts on behalf of another company located in Canada or abroad, then the purchaser would be considered a wholesaler and GUI-0104 does apply. Section 2 (Interpretation) of the Food and Drug Act defines "sell" as "includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration;"
如果采购商没有进行需要许可的活动，并未持有原料药，仅是提供一种服务，则不适用GUI-0401。如果采购商销售或供应原料药销售，代表另一个加拿大公司或海外公司来作为，则采购商被认为是一个批发商，适用GUI-0104。食品药品法第2部分（解释）定义“销售”为“包括提供货物用于销售，参与销售，持有货物用于销售和分销，无论是否考虑将其作为分销”。
6. How will Health Canada verify the compliance of Canadian fabricators, packagers/labellers, testing laboratories, importers, wholesalers and distributors of active ingredients with the amended Food and Drug Regulations? 加拿大卫生局如何核实加拿大的原料药生产商、包装商/标签商、化验室、进口商、批发商和分销商符合修订后的食品药品法？
As of November 8, 2013, a first Good Manufacturing Practices (GMP) inspection of all Canadian API fabricators, packagers/labelers, testing laboratories and importers will be performed according to a risk-based approach. A new inspection strategy for APIs will be available early in 2014 on the Health Canada website.
自2013年11月8日起，所有加拿大原料药生产商、包装商/标签商、检测化验室和进口商的GMP检查将根据基于风险的方法。2014年初加拿大卫生部的网站将会刊出原料药新的检查策略。
Canadian finished dosage form fabricators importing APIs for use in their own manufacturing will be required to demonstrate their compliance with the new GMP requirements during their regular inspection of finished dosage form related activities. Canadian finished dosage form importers will be subject to GMP requirements for the API used in the finished dosage form drugs they import and will be required to demonstrate their compliance with the new GMP requirements during their regular inspection of finished dosage form related activities. Finished Dosage form fabricators and/or importers will continue to be subject to the GMP Inspection Policy for Canadian Drug Establishments (POL-0011).
进口原料药用于其自己的制剂生产的加拿大制剂生产商在其与制剂相关活动常规检查期间，需要证明其符合新的GMP要求。加拿大制剂进口商进口的制剂所用的原料药则需要符合原料药GMP要求，在其常规制剂相关活动中要进行证明。制剂生产商和/或进口商还要继续符合加拿大制药场所GMP检查原则（POL-0011）的要求。
Canadian API distributors and wholesalers, who only store and transport already packaged and labelled APIs, will be subject to the applicable GMP requirements but will not be subject to the API GMP inspection program. However, an inspection may be conducted if a GMP non-compliance issue arises.
加拿大原料药分销商和批发商，如果仅是存贮和运输已经包装和标签好的原料药，则适用GMP要求，但不适用原料药GMP检查计划。但是，如果发生GMP不符合问题，则可能会对其进行检查。
7. Will there be different requirements for active ingredients used in Category IV Monograph drugs, similar to the Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines - Selected Category IV Monograph Drugs (GUI-0066)? 用于IV类各论药品的活性成分有不同相求吗，类似于现行版本GMP指南---选择的IV类各论药品（GUI-0066）附录1？
Pharmaceutical drugs include both prescription and over-the-counter drugs, such as Category IV Monograph drugs. The amended Food and Drug Regulations apply to active ingredients in pharmaceutical drugs for human use. Health Canada has launched a pilot project concerning the implementation of GMP requirements for APIs for selected consumer health products. This pilot project arises in part from Health Canada's commitment, set out in the Regulatory Impact Analysis Statement accompanying the publication of the amended regulations in Part II of the Canada Gazette, to implement the new regulatory requirements in a manner which ensures that the administrative and compliance burden of the requirements is proportional to the quality risks presented by such products. Further initiatives are underway in consultation with affected stakeholders to determine with greater specificity the quality risks associated with API used in the products selected for this pilot, to evaluate current industry practice concerning the qualification of such API, and to develop, where appropriate, specialized GMP guidance pertaining to such API.
药品包括处方药和非处方药，如IV类各论药品。修订后的食品药品法适用于人用药品所含的活性物质。加拿大卫生局刚开始一个关于选择的保健品所用原料药的GMP要求实施试验项目。该试验项目建立的原因与加拿大卫生局的责任有关，这是在加拿大报第II部分修订法出版物一起的法规影响分析声明中说明的，该责任规定加拿大卫生局实施新的法规要求的方式应保证行政和要求符合性负担应与该药品所含的质量风险相称。卫生局还在采取更积极的行动，咨询受影响的利益相关方，来决定此试验项目所选择的药品中所用的原料药所伴随的特有的质量风险，来评估当前制药业关于这种原料药确认的行为规范，并在适当时，建立该原料药所特定的GMP指南。
For more details regarding the pilot project, please refer to the Notice to Stakeholders - Good Manufacturing Practices for Active Pharmaceutical Ingredients - Implementation Pilot Project for Selected Consumer Health Products.
关于试验项目的更多细节，参见“利益相关方通知----活性药物成分GMP----所选择的保健品试验项目的实施”。
加拿大关于进口原料药的新规问答（3/3） 2015-03-04 21:58:17| 分类： 加拿大|
Importation / Foreign Buildings / Foreign Building Table (referenced in Part B Section 5.1 of FRM-0033
进口/国外场所/国外工厂表（FRM-0033第5.1部分第B部）
1. Will the amended Food and Drug Regulations help improve the quality of drugs coming from other countries? 修订后的食品药品法会有助于提高来自其它国家的药品的质量吗？
Yes. The amended Food and Drug Regulations will strengthen the rules that govern drug manufacturing, thereby enhancing the quality and safety of drugs, regardless of whether they come from other countries or are made here in Canada.
是的。修订后的食品药品法将加强药品生产的管理，从而促进药品的质量和安全性，而不论其是来自其它国家还是在加拿大境内生产。
2. How can Canadian importers demonstrate that foreign buildings where active ingredients are fabricated, packaged/labelled and tested are in compliance with regulatory requirements? 加拿大进口商如何证明国外的活性成分场所的生产、包装/标签和检测活性符合法规要求呢？
Canadian importers are required to sign an attestation to demonstrate the Good Manufacturing Practices (GMP) compliance status of the foreign buildings where fabrication, packaging/labelling and/or testing of APIs occur. For the initial phase of the coming into force of the amended Food and Drug Regulations, Health Canada will use these attestations as proof of GMP compliance for non-sterile APIs and it will not be necessary for importers to submit at this time additional GMP evidence such as an inspection report from a trusted international regulator. However, information must be readily available within 48 hours upon request by Health Canada. As and when necessary, Health Canada may also assess foreign buildings for compliance with the applicable GMP requirements in Division 2 of the Food and Drug Regulations.
加拿大进口商要签署一份证明书来证明国外原料药生产、包装/标签和/或检测场所的GMP符合性。在修订后的食品药品法生效的初步阶段，加拿大卫生局将利用这些证明书作为非无菌原料药的GMP符合性证据，这时进口商不需要提交另外的GMP证据，如由可信任的国际法规方出具的检查报告。但是，如果加拿大卫生局要求，信息必须是在48小时内可以获得的。出于必要，或必要时，加拿大卫生局可能还会对国外工厂与食品药品法第2部分中GMP要求适用部分的符合性进行评估。
3. Who is required to sign the attestation for the GMP compliance of the foreign buildings where fabrication, packaging/labelling and/or testing of APIs occur? 谁应该为原料药生产、包装/标签和/或检测的国外场所签署GMP符合性证明？
A Senior Official and the Quality Assurance Official of the Canadian importer are required to sign the attestation.
加拿大进口商的高级管理人员和质量保证人员应签署该证明。
4. After February 8, 2014, if a company changes API foreign suppliers or if a company starts using a new API foreign supplier, must the Foreign Building Information Table be completed and submitted to Health Canada? If yes, is the company required to wait for the approval from Health Canada prior to using the new API foreign supplier? 自2014年2月8日 以后，如果一个公司改变其原料药国外供应商或一个公司开始使用一个新的原料药国外供应商，其国外工厂住处表必须填写完善，并提交给加拿大卫生局吗？如果是，公司是否需要等卫生局批准后才能使用新的国外原料药供应商？
For the initial phase of coming into force of the amended Regulations, Health Canada is using attestations (Part B, section 5.1 of FRM-0033) as proof of GMP compliance for foreign buildings where the fabrication, packaging/labelling and testing of APIs occurs.
在修订后的食品药品法生效后的初始阶段，加拿大卫生局会使用证书（FRM-003的第5.1部分第B部）作为国外原料药生产、包装/标签和检测实施的工厂的GMP符合性证明。
Canadian importers that hold a Drug Establishment Licence (DEL) are required to maintain and provide current, accurate and complete information related to their foreign buildings by submitting an updated API Foreign Building Information Table (referenced in Part B section 5.1 of FRM-0033) to Health Canada before implementing the change. As long as the appropriate paperwork is submitted to Health Canada, companies can import APIs from the new API foreign building, with the exception of API testers and all activities related to sterile APIs. Applicants should keep records of submitting the application and the auto-reply email for that application.
持有药品组织机构许可证书（DEL）的加拿大进口商要向加拿大卫生局提交更新过的国外工厂住处表（FRM-0033第5.1部分第B部），维护、提供与其国外工厂现行的、准确完整的信息。只要将适当的文件提交给了加拿大卫生局，公司就可以从新的原料药国外工厂进口原料药，无菌原料药有关的检测活动及所有活动除外。申报者应保留提交申报的记录和加拿大卫生局对该申报的自动回复邮件。
Applicants are required to inform Health Canada of changes prior to the change taking place. After the initial application is submitted (between November 8 2013 and February 8 2014), follow the same process as above but also complete and submit the first pages of the form (table 1 to 5 of FRM-0033) with your amendment application. If you are amending information in Table A, submit a new Table A and include only the new or modified information relating to the amendment. Companies can import from the new/amended API foreign building as soon as they have filed the amendment (same exceptions above apply).
申报人应在变更发生前将变更通知加拿大卫生局。在初始申报提交后（2013年11月8日 至2014年2月8日之间），按上述相同的流程进行，还要完善和提交表格第一页（FRM-0033表1到5）来提交补充申报。如果你在表格A中增补了住处，则应提交一份新的表格A，只包括与增补有关的新的或修订过的信息。在提交了增补资料后（上述除外情形相同），公司即可以从新的/增补的原料药国外工厂进口物料。
If the amendment is to add a new licensable activity, category or dosage form (for example, starts importing APIs) the company is required to submit the application and have the EL issued by Health Canada prior to starting this new licensable activity.
如果对新的需要许可的活动、类型或剂型（例如，形如进口原料药）有增补，则公司应提交申报，在开始新的需要许可的活动前，要获得加拿大卫生局签发的EL证书。
5. With respect to the API Foreign Building Information Table, is a company expected to keep adding information to the table (cumulative) and submit it to Health Canada? Or is a company expected to only include changes (updated information, additions, deletions) to the table (non-cumulative) and submit to Health Canada? 关于原料药国外工厂信息表，公司是否需要在表中保留（累积）增加的信息并提交给加拿大卫生局？还是只要将变更（更新信息、增加、删除）填入表中（不要累积）提交给卫生局？
After February 8, 2014, companies that change API foreign suppliers or start using a new API foreign supplier are required to provide only changes (updated information, additions, deletions) to the API Foreign Building Information Table (referenced in Part B section 5.1 of FRM-0033) and submit to Health Canada.
在2014年2月8日后，公司变更原料药国外供应商或开始使用新的原料药国外供应商时，只需要提交变更内容（更新信息、增加、删除），填写在原料药国外工厂信息表中（FRM-0033第5.1部分第B部）提交给加拿大卫生部。
6. Will Canada have a Mutual Recognition Agreement for active ingredients like the one it has with other countries for pharmaceutical drugs? 加拿大与其它国家是否有活性成分互认协议，与药品一样？
In the context of drugs, a Mutual Recognition Agreement (MRA) enables countries to share information on the inspections they perform and to accept one another's results as being equivalent. The development and implementation of an MRA requires a thorough analysis and comparison of the inspection programs of the interested parties. It is a long process. Health Canada has been working with international partners towards the inclusion of active pharmaceutical ingredients in our MRAs.
关于药品，互认协议允许国家间共享其实施的检查信息，接受另一方的结果作为等同认可。MRA建立和实施需要一个利益方检查计划的彻底分析和比较，这是一个很长的过程。加拿大卫生局已经与国际伙伴合作来将活性药物成分增加至我们的MRA中。
7. What period of GMP compliance validity will Health Canada assign to foreign buildings where the fabrication, packaging/labelling and testing of active ingredients occurs based on the Attestation form? 加拿大卫生局给原料药生产、包装/标签和检测国外工厂签发的GMP符合性证明表有效期是多长？
At this time, no validity periods or expiry dates will be assigned to API foreign buildings listed on ELs. The interim measure of an attestation process will be in place until mid-2015. During this period, Health Canada will gather and analyse data contained in the Establishment Licence Applications. Based on this analysis, Health Canada will determine the risk-based strategy moving forward.
目前，对EL上列出的原料药国外工厂并没有给定有效期。证书流程的临时措施将在2015年中出台。在此期间，加拿大卫生局将收集和分析EL申报中包含的数据，基于该分析，加拿大卫生局将决定后面的基于风险的策略。
8. Are foreign buildings that perform the required raw material testing on APIs as per Division 2 of the Food and Drug Regulations prior to their use in the fabrication of finished dosage form captured by this regulatory proposal as API testing laboratories? 在其用于制剂生产前，按食品药品法第2部分实施所需原料药检测的国外工厂，是否根据本法规应作为原料药检测化验室？
For foreign buildings that test non-sterile APIs prior to its use in the fabrication of finished products that were already being regulated prior to November 8, 2013, Canadian importers are required to continue submitting GMP evidence as per the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)in addition to submitting the attestation and the Foreign Building Information Table. If a Canadian importer starts using a new foreign building that tests non-sterile APIs prior to its use in the fabrication of finished products on or after November 8, 2013, the Canadian importer is required to submit GMP evidence as per GUI-0080 in addition to submitting the attestation and the Foreign Building Information Table.
在原料药用于制剂生产前对无菌原料药进行检测的国外工厂已在2013年11月8日之前已进行规定。除提交证明书外和国外工厂信息表之外，加拿大进口商要根据“国外工厂GMP符合性证据指南（GUI-0080）”持续提交GMP证据。自2013年11月8日起，如果加拿大进口商开始使用一个新的国外工厂，在原料药用于制剂前，对非无菌原料药进行检测，则除提交证明书和国外工厂信息表外，还应根据GUI-0080提交GMP证据。
9. What level of evidence is required to be on site in Canada for foreign buildings where fabrication, packaging/labelling and testing of APIs occurs? 国外工厂进行原料药生产、包装/标签和检测时，在加拿大的场所需要保留什么 样的证据？
Health Canada has decided to issue a separate guidance document on evidence to demonstrate GMP compliance of API foreign buildings. The guidance document will be available early in 2014 on the Health Canada website. The initial implementation phase of the API regulatory framework is a phase of information-gathering to determine what evidence is currently available on the premises of Canadian importers. Inspectors will be taking a look at this evidence during inspections and assess compliance with Division 2 of the Food and Drug Regulations.
加拿大卫生局已决定签发一份关于证明国外原料药工厂GMP符合性的单独指南文件。该指南文件将在2014年早些时候可以从加拿大卫生局获得。原料药法规框架初步实施阶段为信息收集阶段，用以决定目前在加拿大进口商的场所内有哪些可以获得的证据。检查人员将在检查期间查看这些证据，并评估其与食品药品法第2部分的符合性。
来源：http://zhuyujiao1972.blog.163.com/
|手机版|药群论坛
( 蜀ICP备15007902号 )
收藏
支持
反对