Vitafoods eu clinical trials regulationAxon Lawyers
The document discusses the key changes to the legal framework for clinical trials in the EU under the new Clinical Trials Regulation, including streamlined application procedures, a single submission process, increased transparency requirements, and clarification around what products are considered medicinal products versus food or dietary supplements.
Vitafoods B2C communication in the funtional food Axon Lawyers
1) The document discusses the legal framework for health, nutrition, and medical claims regarding functional foods and nutraceuticals in B2C communication in the EU.
2) It outlines the differences between nutrition claims, health claims, and medical claims and the conditions for using each type of claim. Nutrition claims relate to nutrient content while health claims relate the relationship between a food and health. Medical claims are not allowed for foods.
3) The document also discusses requirements for food information to consumers regarding ingredients, legibility, and nutrition declarations according to the Food Information to Consumers Regulation.
Vitafoods marketing functional food to childrenAxon Lawyers
The document discusses marketing functional foods to children in the EU. It outlines WHO recommendations to reduce marketing of unhealthy foods to children. In the EU, health claims must meet strict criteria and not mislead consumers. National self-regulatory bodies in countries like the Netherlands set rules for food advertising to children, generally prohibiting advertising of foods high in fat, sugar, or salt for children under 12. Effectiveness of self-regulation is debated as some find additional restrictions are still needed.
Vitafoods Europe 2015: Clearer labels for consumersAxon Lawyers
The document summarizes the key aspects of the EU Food Information for Consumers Regulation, which aims to modernize and clarify food labeling requirements for consumers. It overviews the scope of the regulation, mandatory food information that must be included like ingredients and country of origin, new legibility requirements, and the upcoming mandatory nutrition declaration. It concludes that the regulation will increase administrative burden for industry but is intended to better support consumer choice and rebuilt trust following food scandals.
The document summarizes the current status and future changes to novel food regulations in the EU. It discusses the four categories of novel foods, the authorization procedures, examples of novel foods that have received authorization, and how specific novel foods like algae, insects and duckweed are currently treated. It notes that the new regulations will centralize the authorization process and create a simplified procedure for traditional foods, while introducing provisions around nanomaterials and cloned animals.
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and European citizens' negative perceptions of the technique.
Vitafoods eu clinical trials regulationAxon Lawyers
The document discusses the key changes to the legal framework for clinical trials in the EU under the new Clinical Trials Regulation, including streamlined application procedures, a single submission process, increased transparency requirements, and clarification around what products are considered medicinal products versus food or dietary supplements.
Vitafoods B2C communication in the funtional food Axon Lawyers
1) The document discusses the legal framework for health, nutrition, and medical claims regarding functional foods and nutraceuticals in B2C communication in the EU.
2) It outlines the differences between nutrition claims, health claims, and medical claims and the conditions for using each type of claim. Nutrition claims relate to nutrient content while health claims relate the relationship between a food and health. Medical claims are not allowed for foods.
3) The document also discusses requirements for food information to consumers regarding ingredients, legibility, and nutrition declarations according to the Food Information to Consumers Regulation.
Vitafoods marketing functional food to childrenAxon Lawyers
The document discusses marketing functional foods to children in the EU. It outlines WHO recommendations to reduce marketing of unhealthy foods to children. In the EU, health claims must meet strict criteria and not mislead consumers. National self-regulatory bodies in countries like the Netherlands set rules for food advertising to children, generally prohibiting advertising of foods high in fat, sugar, or salt for children under 12. Effectiveness of self-regulation is debated as some find additional restrictions are still needed.
Vitafoods Europe 2015: Clearer labels for consumersAxon Lawyers
The document summarizes the key aspects of the EU Food Information for Consumers Regulation, which aims to modernize and clarify food labeling requirements for consumers. It overviews the scope of the regulation, mandatory food information that must be included like ingredients and country of origin, new legibility requirements, and the upcoming mandatory nutrition declaration. It concludes that the regulation will increase administrative burden for industry but is intended to better support consumer choice and rebuilt trust following food scandals.
The document summarizes the current status and future changes to novel food regulations in the EU. It discusses the four categories of novel foods, the authorization procedures, examples of novel foods that have received authorization, and how specific novel foods like algae, insects and duckweed are currently treated. It notes that the new regulations will centralize the authorization process and create a simplified procedure for traditional foods, while introducing provisions around nanomaterials and cloned animals.
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and European citizens' negative perceptions of the technique.
EU Food Regulation on Additives, Novel Foods and Food Contact MaterialsDaniele Pisanello
The presentation has been used within the EIPA's Seminar "Introduction to the fundamentals of EU Food Law: principles, procedures & main regulatory components", 7 and 13 of Luly 2016, on behalf of European Commission, DG Translation.
It provides an introduction to specific legal standards relating to food additives, novel foods and food contact materials.
20141105 Seminario Información al Consumidor - CDFIAB
The document discusses recent developments related to Regulation (EU) No 1169/2011 on food information to consumers, including:
1) New questions and answers on the application of the regulation and upcoming publications on nutrition and general labelling.
2) Adaptation of the definition of engineered nanomaterials to include a new threshold and exemptions.
3) Mandatory origin labelling for certain meats and reports on extending these requirements to other foods.
4) National measures on providing allergen information for non-prepacked foods and debates around harmonizing these rules.
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
1) The document discusses the legal framework for classifying life sciences products, such as foods, medicinal products, and medical devices.
2) It analyzes case law that has established criteria for determining if a product is a medicinal product based on its presentation or function.
3) The document provides guidance on how to obtain approval for health claims about products and how to respond if a product's classification is challenged by regulators.
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
The Falsified Medicines Directive - Regulation Driving DigitisationAegate
The document discusses the Falsified Medicines Directive, a new EU regulation aimed at protecting patients from counterfeit medications. It will require unique identification and authentication of prescription drug packages. This will create a digital network connecting manufacturers, distributors, pharmacies, and patients. While it imposes new costs, it also presents opportunities to improve supply chain efficiency and patient safety. Aegate advocates for national verification systems using standardized technology to ensure authentication across Europe. The regulation will transform healthcare by digitizing the pharmaceutical supply chain.
Ms. Connie Lau discusses food additives from the consumer's perspective. She summarizes tests conducted by the Hong Kong Consumer Council that found various food additives, like sulphur dioxide and benzoic acid, in dried fruits and vegetarian foods at varying concentrations that were not fully disclosed on labels. This lack of information causes ignorance among consumers about what they are eating. She advocates for providing more information to consumers in accordance with UN Guidelines for Consumer Protection to address ignorance and allay fears. While food additives are controversial, consumers accept their necessity but want representation in decision making to have their voices heard on food safety issues.
Brominated vegetable oils (BVOs) are used as emulsifiers in some fruit-flavored beverages to suspend flavor oils and give a cloudy appearance. However, the safety of BVOs was questioned in the 1970s due to findings of toxicity in animal studies. As a result, regulatory bodies have not established an acceptable daily intake for BVOs and most no longer consider them safe food additives. In Hong Kong, BVOs are not permitted as food additives and the government continues active surveillance to prevent their use in local foods. Alternatives exist that can achieve the same technical functions as BVOs without the potential health risks.
The document summarizes the key points of the SPS Agreement, which establishes rules for food safety, animal and plant health standards in international trade. It entered into force in 1995 with the establishment of the WTO. The agreement aims to allow countries to set health standards while preventing unjustified barriers to trade. It outlines 10 principles member countries should follow, including basing measures on risk assessments, ensuring transparency, and controlling diseases and pests. Complying with the agreement benefits member countries by improving market access.
1) The document discusses the role of sanitary and phytosanitary measures in international trade agreements. It outlines some of the challenges faced by the EU and US in bilateral trade negotiations, including differences in rules around issues like animal welfare, food safety standards, and pesticide use.
2) The EU wishes to address more issues in bilateral trade agreements than are currently covered in existing veterinary agreements with countries like the US. The EU wants to push principles around animal welfare, antibiotics use, and geographical indications of food products.
3) Negotiating bilateral trade agreements presents both opportunities to advance important EU policies and principles internationally, but also threats if the EU has to compromise on key positions to achieve more balanced
This document proposes strengthening regulations for the recycling of waste cooking oils (WCO) generated by restaurants and food factories in Hong Kong. It suggests introducing licenses for WCO collection, disposal, and import/export. Operators without licenses would face fines or imprisonment. It also proposes that restaurants and food factories be required to hand over their WCO only to licensed collectors and keep transaction records. The Environmental Protection Department will implement a voluntary registration system for WCO operators and develop best practices to facilitate proper handling and recycling of WCO.
The document provides information on recent updates to the EU Falsified Medicines Directive and its requirements for safety features on medication packaging to help prevent falsified medicines. It discusses the growing problem of falsified medicines in Europe, the goals of the Falsified Medicines Directive to strengthen regulation of the pharmaceutical supply chain, and the delegated regulation outlining technical specifications for unique identifiers and anti-tampering devices that must be implemented by February 2019. It also addresses the roles and responsibilities of various stakeholders including marketing authorization holders, manufacturers, wholesalers, pharmacies and regulatory authorities in complying with the new regulations.
Mutual recognition is an EU principle that requires member states to allow goods legally sold in another member state to be sold in their own territory. This eliminates the need for duplicate testing and certification in importing countries. Mutual recognition agreements between countries or regions formalize this principle for international trade by designating conformity assessment bodies whose test results and certifications are mutually recognized. The EU-US MRA allows regulators to rely on each other's drug inspections to avoid duplication and increase efficiencies.
Standards and related issues in the WTO Agreement on SPS and TBTFAO
Ahmad Mukhtar
Economist -Trade and Food Security, FAO Liaison Office Geneva
Materials of the workshop on Resolving agricultural trade issues through the WTO organized by FAO in collaboration with Ukraine’s Ministry of Agrarian Policy and Food of Ukraine in Kyiv on June 7, 2017.
http://www.fao.org/economic/est/est-events-new/wtokiev/en/
http://www.fao.org/europe/news/detail-news/en/c/892730/
International Regulatory Overview 2009 Rev LinkedlnMdbio
Roger Leclerc presented on international medical device regulatory challenges and overviews. He discussed regulatory bodies and their challenges in Canada, the US, Europe, Australia and Asia. For Health Canada, he outlined strategic objectives like modernization, adequate funding, and improved governance. Key regulatory issues from 2008-2009 included standards recognition, special access programs, significant changes, and sale of unlicensed devices.
Thank you for the summary. Here are a few key points I noticed:
- GCP provides an international quality standard for clinical research to protect participants and ensure reliable data.
- It has evolved in response to past abuses and aims to harmonize standards across countries/regions.
- Key roles include sponsors to design/manage studies, principal investigators to oversee local research, and staff to conduct study procedures.
- Regulations like the Code of Federal Regulations codify GCP principles to facilitate compliance.
Overall this helps explain the purpose and scope of Good Clinical Practice as an important framework in clinical research. The summary effectively distills the main points from the lengthy document.
Novel foods and animal cloning era 5 may 2014Axon Lawyers
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and citizens' negative perceptions of the technique.
How can CBD still be applied in food products after the most recent change in the Novel Food Catalogue, according to which CDB foods are, in principle, Novel Foods?
EU Food Regulation on Additives, Novel Foods and Food Contact MaterialsDaniele Pisanello
The presentation has been used within the EIPA's Seminar "Introduction to the fundamentals of EU Food Law: principles, procedures & main regulatory components", 7 and 13 of Luly 2016, on behalf of European Commission, DG Translation.
It provides an introduction to specific legal standards relating to food additives, novel foods and food contact materials.
20141105 Seminario Información al Consumidor - CDFIAB
The document discusses recent developments related to Regulation (EU) No 1169/2011 on food information to consumers, including:
1) New questions and answers on the application of the regulation and upcoming publications on nutrition and general labelling.
2) Adaptation of the definition of engineered nanomaterials to include a new threshold and exemptions.
3) Mandatory origin labelling for certain meats and reports on extending these requirements to other foods.
4) National measures on providing allergen information for non-prepacked foods and debates around harmonizing these rules.
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
1) The document discusses the legal framework for classifying life sciences products, such as foods, medicinal products, and medical devices.
2) It analyzes case law that has established criteria for determining if a product is a medicinal product based on its presentation or function.
3) The document provides guidance on how to obtain approval for health claims about products and how to respond if a product's classification is challenged by regulators.
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
The Falsified Medicines Directive - Regulation Driving DigitisationAegate
The document discusses the Falsified Medicines Directive, a new EU regulation aimed at protecting patients from counterfeit medications. It will require unique identification and authentication of prescription drug packages. This will create a digital network connecting manufacturers, distributors, pharmacies, and patients. While it imposes new costs, it also presents opportunities to improve supply chain efficiency and patient safety. Aegate advocates for national verification systems using standardized technology to ensure authentication across Europe. The regulation will transform healthcare by digitizing the pharmaceutical supply chain.
Ms. Connie Lau discusses food additives from the consumer's perspective. She summarizes tests conducted by the Hong Kong Consumer Council that found various food additives, like sulphur dioxide and benzoic acid, in dried fruits and vegetarian foods at varying concentrations that were not fully disclosed on labels. This lack of information causes ignorance among consumers about what they are eating. She advocates for providing more information to consumers in accordance with UN Guidelines for Consumer Protection to address ignorance and allay fears. While food additives are controversial, consumers accept their necessity but want representation in decision making to have their voices heard on food safety issues.
Brominated vegetable oils (BVOs) are used as emulsifiers in some fruit-flavored beverages to suspend flavor oils and give a cloudy appearance. However, the safety of BVOs was questioned in the 1970s due to findings of toxicity in animal studies. As a result, regulatory bodies have not established an acceptable daily intake for BVOs and most no longer consider them safe food additives. In Hong Kong, BVOs are not permitted as food additives and the government continues active surveillance to prevent their use in local foods. Alternatives exist that can achieve the same technical functions as BVOs without the potential health risks.
The document summarizes the key points of the SPS Agreement, which establishes rules for food safety, animal and plant health standards in international trade. It entered into force in 1995 with the establishment of the WTO. The agreement aims to allow countries to set health standards while preventing unjustified barriers to trade. It outlines 10 principles member countries should follow, including basing measures on risk assessments, ensuring transparency, and controlling diseases and pests. Complying with the agreement benefits member countries by improving market access.
1) The document discusses the role of sanitary and phytosanitary measures in international trade agreements. It outlines some of the challenges faced by the EU and US in bilateral trade negotiations, including differences in rules around issues like animal welfare, food safety standards, and pesticide use.
2) The EU wishes to address more issues in bilateral trade agreements than are currently covered in existing veterinary agreements with countries like the US. The EU wants to push principles around animal welfare, antibiotics use, and geographical indications of food products.
3) Negotiating bilateral trade agreements presents both opportunities to advance important EU policies and principles internationally, but also threats if the EU has to compromise on key positions to achieve more balanced
This document proposes strengthening regulations for the recycling of waste cooking oils (WCO) generated by restaurants and food factories in Hong Kong. It suggests introducing licenses for WCO collection, disposal, and import/export. Operators without licenses would face fines or imprisonment. It also proposes that restaurants and food factories be required to hand over their WCO only to licensed collectors and keep transaction records. The Environmental Protection Department will implement a voluntary registration system for WCO operators and develop best practices to facilitate proper handling and recycling of WCO.
The document provides information on recent updates to the EU Falsified Medicines Directive and its requirements for safety features on medication packaging to help prevent falsified medicines. It discusses the growing problem of falsified medicines in Europe, the goals of the Falsified Medicines Directive to strengthen regulation of the pharmaceutical supply chain, and the delegated regulation outlining technical specifications for unique identifiers and anti-tampering devices that must be implemented by February 2019. It also addresses the roles and responsibilities of various stakeholders including marketing authorization holders, manufacturers, wholesalers, pharmacies and regulatory authorities in complying with the new regulations.
Mutual recognition is an EU principle that requires member states to allow goods legally sold in another member state to be sold in their own territory. This eliminates the need for duplicate testing and certification in importing countries. Mutual recognition agreements between countries or regions formalize this principle for international trade by designating conformity assessment bodies whose test results and certifications are mutually recognized. The EU-US MRA allows regulators to rely on each other's drug inspections to avoid duplication and increase efficiencies.
Standards and related issues in the WTO Agreement on SPS and TBTFAO
Ahmad Mukhtar
Economist -Trade and Food Security, FAO Liaison Office Geneva
Materials of the workshop on Resolving agricultural trade issues through the WTO organized by FAO in collaboration with Ukraine’s Ministry of Agrarian Policy and Food of Ukraine in Kyiv on June 7, 2017.
http://www.fao.org/economic/est/est-events-new/wtokiev/en/
http://www.fao.org/europe/news/detail-news/en/c/892730/
International Regulatory Overview 2009 Rev LinkedlnMdbio
Roger Leclerc presented on international medical device regulatory challenges and overviews. He discussed regulatory bodies and their challenges in Canada, the US, Europe, Australia and Asia. For Health Canada, he outlined strategic objectives like modernization, adequate funding, and improved governance. Key regulatory issues from 2008-2009 included standards recognition, special access programs, significant changes, and sale of unlicensed devices.
Thank you for the summary. Here are a few key points I noticed:
- GCP provides an international quality standard for clinical research to protect participants and ensure reliable data.
- It has evolved in response to past abuses and aims to harmonize standards across countries/regions.
- Key roles include sponsors to design/manage studies, principal investigators to oversee local research, and staff to conduct study procedures.
- Regulations like the Code of Federal Regulations codify GCP principles to facilitate compliance.
Overall this helps explain the purpose and scope of Good Clinical Practice as an important framework in clinical research. The summary effectively distills the main points from the lengthy document.
Novel foods and animal cloning era 5 may 2014Axon Lawyers
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and citizens' negative perceptions of the technique.
How can CBD still be applied in food products after the most recent change in the Novel Food Catalogue, according to which CDB foods are, in principle, Novel Foods?
This document discusses biosafety regulations in food technology. It begins by defining food safety and safe food, then discusses reasons for concern about food safety such as changes in food habits and globalization of food trade. It outlines the need for regulations in the food supply chain and various initiatives taken at international level like Codex Alimentarius Commission established in 1962 to set food standards. The document then discusses India's food safety legislation, the Food Safety and Standards Authority of India (FSSAI) established under the Food Safety and Standards Act, 2006. It provides details on the objectives, functions, implementation structure, licensing requirements, and various regulations under FSSAI including standards for food products, food additives, contaminants and more.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
FOOD AND NUTRACEUTICALS REGULATION IN INDIAChandanBV2
This document provides an overview of regulations for nutraceuticals and functional foods in India. It discusses key terms like nutraceuticals and functional foods. It outlines the history and timeline of food regulations in India, describing various national laws established. It explains the Food Safety and Standard Act of 2006, which aims to establish a single reference point for all food safety matters. The document also discusses licensing and registration requirements for nutraceuticals under FSSAI, labeling requirements, and the regulatory requirements for entering the Indian nutraceutical market.
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
Canadian Regulatory Aspects of Gene Editing Technologies - Christine TibeliusOECD Environment
This presentation addresses the regulatory questions associated with genome editing applications in agriculture in Canada, with a view to discussing approaches to address them.
OS16 - 4.P1.f EU Authorisation of Novel Vaccines - M. IlottEuFMD
The document discusses the regulatory requirements and processes for obtaining marketing authorization for a live recombinant veterinary vaccine for foot-and-mouth disease in the European Union. It outlines the relevant EU regulations and directives, technical requirements for the vaccine including safety and efficacy studies, and routes for scientific advice from the European Medicines Agency during development.
A recap and summary of the two day course, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
• Further reading and resources
Legal and regulatory aspects of functional and medical foodsAxon Lawyers
1. The document discusses the legal frameworks governing functional foods and medical foods in the EU and Netherlands. It outlines key definitions and requirements for these categories of foods.
2. For medical foods, regulations establish composition standards and require they are only used under medical supervision. Claims on medical foods are limited mainly to general nutrition functions. Food information regulations also apply.
3. Functional foods have no single regulatory definition and are subject to various laws depending on their attributes. Nutrition and health claims may be used if scientific evidence and conditions of use are met. The food information regulation introduces new labeling requirements.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
Best practice part a compliance management-Woody WangSimba Events
This document provides an overview of Selerant's food compliance management service. It discusses laws and regulations management, including searching and structuring food laws and regulations data from over 100 countries. It also covers managing raw material specifications, calculating raw material compliance against limits in laws and regulations, and calculating formula compliance. The document includes screenshots demonstrating how Selerant's software allows users to perform these compliance management tasks in a structured manner using its global food laws and regulations database.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview and describes the recent TGA public consultation on the exclusion of some autologous cell therapies from regulation.
This document discusses biosimilars and their regulation. It begins with a brief history of biotechnology and biopharmaceuticals. It then defines biosimilars as similar but not generic versions of biologic drugs whose patents have expired. The document outlines key differences between biosimilars and generic drugs, including their larger and more complex molecular structures. It also discusses concerns regarding biosimilar efficacy, safety, interchangeability, and pharmacovigilance. Finally, it provides an overview of regulatory frameworks for biosimilars in various regions like the EU, US, India, and WHO guidelines.
3.the status of functional foods in taiwan 0917Peerasak C.
The document discusses the status of functional foods in Taiwan. It outlines Taiwan's Health Food Control Act and regulations regarding health food permits. There are two tracks for obtaining a health food permit - Track 1 involves individual assessment of a product's safety, stability and health effects, while Track 2 involves ingredients that conform to health food specification standards. The key criteria for a health food are safety assessment, stability evaluation, and demonstration of approved health care effects. The document also provides an overview of Taiwan's functional food market and industry ecosystem.
Investigation of Medicinal Product Dossier (IMPD) and Investigator Brochure (...Tanvi Mhashakhetri
This document provides an overview of an Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB). It begins with background on the European Medicines Agency and drug approval process. It then describes the contents and objectives of an IMPD, which includes quality, manufacturing, and clinical data submitted as part of a clinical trial application. Next, it introduces the IB and lists components like the product description, nonclinical study results, effects in humans, and guidance for investigators. The document aims to define harmonized IMPD requirements for clinical trials involving multiple EU member states.
Similar to Vitafoods - Alternative Sources of Protein (20)
Seminar General Data Protection RegulationAxon Lawyers
The document summarizes key points from a seminar on data protection and the new General Data Protection Regulation (GDPR). It discusses definitions of personal data and health data, consent requirements, privacy by design, data transfers, security obligations, data breaches, the data protection officer role, and impact assessments. The new GDPR brings significant changes including tougher consent standards, higher fines for violations, additional rights for data subjects, and new responsibilities for processors. Member states still have flexibility in some implementation areas, and full compliance will require preparation.
This document summarizes key aspects of data protection regulations including the transition from the Data Protection Directive (DPD) to the General Data Protection Regulation (GDPR). It discusses definitions of personal data and health data, requirements around anonymization and pseudonymization, consent requirements, research data protections, data transfer and security rules, and new obligations to notify authorities of data breaches. The presentation concludes with contact information for Sofie van der Meulen of Axon Advocaten law firm in Amsterdam.
Paperless Lab Academy 'legal aspects of big data analytics' Axon Lawyers
This document provides an overview of legal aspects related to big data analytics. It defines big data and discusses legal perspectives on data protection and privacy in the context of big data. The document outlines how the collection and analysis of large datasets can constitute processing of personal data, raising issues of consent, data minimization, anonymization, and security. It also discusses how regulations like the EU's General Data Protection Regulation aim to address privacy challenges from big data while balancing opportunities for innovation.
Hacking Health Camp Strasbourg health data & data protection in the Netherlands Axon Lawyers
This document summarizes key points about data protection and privacy in the Netherlands. It discusses the legal framework for data protection in the EU and Netherlands, including the Data Protection Directive, upcoming General Data Protection Regulation, and the Dutch Data Protection Authority. It covers definitions of personal data, parties involved in processing, rules around health data, data security, and recent developments around data breaches. The document also flags other legal issues that may be relevant for digital health technologies, like software qualifying as a medical device.
Conveying food innovations by health claimsAxon Lawyers
This document provides an overview of the legal framework for nutrition and health claims in the European Union and examples of how food innovations have conveyed through claims. It begins with definitions of nutrition claims and health claims and the authorization process. Two case studies are presented: a proprietary claim for plant sterol esters lowering cholesterol, and a claim for lycopene supporting platelet aggregation. The document concludes with a quiz to test understanding of claim types and conditions of use.
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2. Agenda
• Rationale
• Legal framework alternative protein products
• Relevance for nutraceuticals
• Examples
• Implications of Novel Foods legislation
2
3. Alternative sources of protein.
Why?
Reason # 1 to eat less meat: Health
• Scientific report WHO (26 October 2015)
Consumption of processed meat increases colon cancer risk.
• Dutch Health Council, Guidelines Healthy Food
(4 November 2015):
Promotes a diet containing more plant based than
animal based proteins.
3
4. 4
Reason # 2: to eat less meat: Sustainability
• Current food production methods require too much natural resources to
be sustainable in 2050 (expectation: 9 billion people to feed).
• In-balance in consumption: > 1 billion people overweight, 800 million
people undernourished.
• Increased prosperity increased meat consumption, e.g. in China
(1,3 billion inhabitants vs. 500 million inhabitants in Europe)
Alternative sources of protein.
Why?
5. 5
Reason # 3: to eat less meat: Animal welfare
• Although breeding of animals is regulated and well-being of animals is
controlled, bottom line: less animal consumption is less animals killed.
• Outbreak of infectious diseases resulted into massive slaughter of
animals, e.g. swine fever and mad-cow disease.
• Today, many meat alternatives.
Alternative sources of protein.
Why?
6. Legal framework alternative
protein products
6
• Novel Foods legislation is applicable framework for many protein rich
products.
• What are Novel Foods? Food products that have not been used for
human consumption to a significant degree within the EU prior to 1997.
• Cut-off date refers to current Novel Foods Regulation in need of
reform for several reasons:
(1) streamlining authorisation procedure;
(2) keeping up with technological & scientific developments;
(3) facilitating introduction of traditional foods from third
countries into EU.
7. Relevance for nutraceuticals?
7
• Nutraceuticals are subject to existing EU food laws which are
implemented on a national basis in all EU Member States.
• There is no particular ‘Nutraceutical Regulation’, but the food or
ingredient may be classed as "novel" and therefore require
authorization under the EU Novel Foods Regulation.
8. Legal framework alternative
protein products
8
Revision NF-Regulation in a nutshell
• December 2013: Commission proposal
• 16 November 2015: EP proposal accepted by Council
• Entry into force: publication in OJ + 20 days (early 2016)
• Date of application: 2 years after entry into force (transition regime)
9. Legal framework alternative
protein products
9
Major changes of new NF-Regulation comprise:
(1) one centralized procedure for NF assessment and authorisation;
(2) simplified procedure for marketing traditional foods from third countries;
(3) Definition of “Novel Food” considerably broadened: 4 10 categories
10. Legal framework alternative
protein products
10
Centralised procedure for NF assessment & authorisation
• Pre-market authorisation requested directly from the
Commission instead of from the MS authorities.
• If Commission requests safety opinion EFSA shall
render such opinion within 9 months from request.
• Publication of draft authorisation decision within 7 months of EFSA
opinion.
• System of individual authorization replaced by system of generic
authorizations
• Simplified procedure based on substantial equivalence will cease to
exist.
11. Legal framework alternative
protein products
11
Simplified procedure for marketing traditional foods
• History of safe use in a non-EU country for > 25 years should be
demonstrated.
• Authorization if within 4 months after notification to Commission, no
reasonable safety objections are received Union list.
• Any safety objections? EFSA opinion requested within 6 months of
valid application.
• Commission shall publish draft authorisation
within 3 months after publication of safety opinion.
12. Legal framework alternative
protein products (6)
12
Broadened product definition of Novel Food, including
• food consisting of or isolated / produced from:
13. Examples: algae (1)
13
• Algae are explicitly mentioned as being Novel Foods
• 2 granted authorisations for algae based products (algal oil)
• Many algae already marketed in EU prior to 1997. Examples include:
(1) Chlorella pyrenoidosa (sorokiniana)
Not subject to Novel Food legislation
(2) Laminaria digitata
Not subject to Novel Food legislation
(3) Rhodymenia palmata
Only used as a food supplement in the EU prior to 1997
14. Examples: algae (2)
14
• EU Novel Foods Catalogue
http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/mod_sear
ch/index.cfm
History of safe use; no NF authorization required
Only use as food supplement is known; NF authorization required
No history of safe use apparent from previous application:
NF authorization required
Further information required
15. Examples: algae (3)
15
The Dutch Weed Burger also contains 2 types of algae:
• burger Royal Kombu (Laminaria saccharina)
• bun Chlorella sorokiniana (+ soy snips)
Both types of algae have a history of safe use in Europe predating 1997
outside the scope of the Novel Foods legislation.
16. Examples: cultured meat burger
16
“Mark Post” burger is a typical Novel Food.
• Maastricht Prof. produces meat from cow cells outside the cow.
• He takes a few cells from a cow that divide by themselves, provides
anchor points that will grow into muscle.
• Such high tech product will need to obtain NF clearance. And the
Professor knows about it.
17. Examples: MushroomMeat
17
MushroomMeat
• Combination of mushroom mycelium (roots & stems) + substrate
(growth medium).
• Mycelium is more concentrated than mushroom fruit body and can be
quickly cultivated (2 > 5 weeks).
• Various sorts of substrate are possible to vary in taste, such as grains,
carrots, pumpkin, shrimps shells or oat.
• Sterile production process is based on solid state fermentation.
• However this production process is new safety must be confirmed on
the basis of a NF-authorisation.
18. Examples: insects
18
• New: insects are considered Novel Food ingredients under new NF-
Regulation.
• Contrary to practise in various Member States: Belgium and Holland
19. Examples: insects
19
EFSA scientific opinion 8 October 2015:
a. production method
b. the substrate used
c. stage of harvest
d. insect species and
e. method of further processing
Relevant for risk evaluation currently only limited data available
further research recommended.
• No immediate safety concerns. Shouldn’t insects be considered ‘safe’
under food law?
• ‘Safe’ in food law means: food is safe until unsafely has been found.
20. Implications of NF-legislation (1)
20
Implications depend on type of product
• Cultured meat burger and MushroomMeat will defenitely be subject to
NF-authorization procedure.
• Algae products may not need authorisation at all, depending on type.
• For insect products, a distinction should be made for products marketed
now and in future.
21. Implications of NF-legislation (2)
21
Insect based products and transition regime
• Products currently marketed do not need to be removed from market.
• However, for continued marketing an authorization should be requested
before 2 years after the date of application of the new NF-Regulation.
• Also, future insect based products will – according to the new Regulation
also need to request a market authorization.
• In this in line with created expectations at national levels?
.
22. Implications of NF-legislation (3)
22
Requirements authorization procedure
In future, authorizations will be generic check Union List.
No third party authorizations? individual application for authorization
need to be filed substantiating the following.
• specification of the Novel Food
• effects of the applied production process
• background info on source of Novel Food
• expected uptake / frequency of use
• nutritional value
• microbiological information
• toxicological information
23. Conclusions
23
1. Begin with the end in mind: before manufacturing and marketing an
alternative protein product, know its regulatory status.
2. If the product/ingredient of your choice falls within the NF-legislation,
pick the one for which a history of safe use exists (e.g. algae).
3. If no history of safe use exists, check the future Union List for third
party authorizations.
4. Only when no third party authorizations have been published, you
should file an application for NF-authorisation.
24. Sofie van der Meulen
Axon Advocaten
Piet Heinkade 183
1019 HC Amsterdam
+31 88 650 6500
+31 6 53 44 05 67
sofie.vandermeulen@axonlawyers.com
Editor's Notes
microorganisms, fungi or algae;
cell or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
plants or their parts, except when the food has a history of safe food use in the Union and one out of two alternative conditions are met;
animals or their parts, except where these animals were obtained from traditional breeding practises and the food from those animals has a history of safe food use;
(1) Algae belongs to the Chlorophytae Family, grown in Japan, China and Taïwan since 1955. Composition is quite similar to the other macroalgae. It is a nutrient-dense unicellular fresh water green alga .
(2) Large kelp up to 2 m in length commonly found at low water during spring tides on rocky shores in the north west Atlantic from Greenland south to Cape Cod and in the north east Atlantic from northern Russia and Iceland south to France.
(3) Seaweed specie of 20 to 30 cm in length. Aquatic plant living on the rocks. Geographic distribution spreads on the coasts of the Manche, the Atlantic Ocean, Greenland and France.
EFSA was requested to assess the micro-biological, chemical and environmental risks posed by the use of insects in food relative to the risks posed by the use of other protein sources in food.
As to products providing alternative protein, such as insects, we understand that the safety aspects from rearing to consumption should be carefully assessed. However, we note that EFSA does not have any immediate safety concerns per se. Furthermore, it should be stressed that the notion of “safety” in EU food law has only been negatively defined. That is, food is safe as long as it is was not found unsafe. Therefore, we consider that alternative protein products that were marketed for a number of years without any problems reported should not be subject to further barriers.