Under definition of Advanced Therapy Medicinal Product fall all products for humans intended for gene therapy and somatic cell or that contains or consists of engineered cells or tissues or is administered to human beings with a view to regenerating, repairing or replacing human a tissue. It is not unusual that an Advanced Therapy Medicinal Product looks more like a medical device but is treated by regulatory authorities rather like a medicinal product.
Under definition of Advanced Therapy Medicinal Product fall all products for humans intended for gene therapy and somatic cell or that contains or consists of engineered cells or tissues or is administered to human beings with a view to regenerating, repairing or replacing human a tissue. It is not unusual that an Advanced Therapy Medicinal Product looks more like a medical device but is treated by regulatory authorities rather like a medicinal product.
In the European Union Advanced Therapy Medicinal Products are regulated by the EU Regulation EC 1394/2007. The European Commission and Notified bodies treat Advanced Therapy Medicinal Products as medicinal products. These products are subject to the centralized authorization procedure in the EU, i.e. product dossiers are submitted directly to the EMA (European Medicines Agency).
There are special regulations pertaining to the Advanced Therapy Medicinal Products in the USA - 21 CFR Part 1270 and 21 CFR Part 1271 and a number of guidances for different types of Advanced Therapy Medicinal Products.
Mostly, regulatory authorities in the Latin American countries view Advanced Therapy Medicinal Products as medicines. However, the regulatory pathway for such products often deviate from traditional regulatory processes typical for drugs; often regulatory decisions are made by the authorities on a case-by-case basis.
In the European Union Advanced Therapy Medicinal Products are regulated by the EU Regulation EC 1394/2007. The European Commission and Notified bodies treat Advanced Therapy Medicinal Products as medicinal products. These products are subject to the centralized authorization procedure in the EU, i.e. product dossiers are submitted directly to the EMA (European Medicines Agency).
There are special regulations pertaining to the Advanced Therapy Medicinal Products in the USA - 21 CFR Part 1270 and 21 CFR Part 1271 and a number of guidances for different types of Advanced Therapy Medicinal Products.
Mostly, regulatory authorities in the Latin American countries view Advanced Therapy Medicinal Products as medicines. However, the regulatory pathway for such products often deviate from traditional regulatory processes typical for drugs; often regulatory decisions are made by the authorities on a case-by-case basis.
MDRC assists manufacturers with regulatory approvals and placing Advanced Therapy Medicinal Products on the European, USA and Latin American markets regardless of how complicated are regulatory processes that their products incur.
MDRC assists manufacturers with regulatory approvals and placing Advanced Therapy Medicinal Products on the European, USA and Latin American markets regardless of how complicated are regulatory processes that their products incur.
New promising Advanced Therapy Products are investigated every year by pharmaceutical and biotechnology companies, as well as doctors and academics, for their potential to treat diseases. The research and development process must be documented. The documents should describe the development processes including preclinical and clinical development, safety, efficacy and quality of a product. These documents are placed in the product's dossier. Many of them will be submitted to regulatory authorities.
During development of an Advanced Therapy Medicinal Product, a developer can request guidance and direction from some regulatory authorities (e.g. from EMA, FDA) on the best methods and study designs to generate robust information on how well a medicine works and how safe it is. This is known as scientific advice.
Manufacturer submits data to the regulatory authorities in countries where the company wants to sell the product. The data submitted by medicine developers in their application for marketing authorization must comply with local legislation. They must include a range of information, including on the way the Advanced Therapy Medicinal Product is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors.
Based on the assessment regulatory authorities develop an opinion whether the product can be placed on the market and used as stated by the manufacturer. In different countries the market access can be granted either by regulatory agencies responsible for pharmaceuticals and medical devices or some other governmental bodies.
Once an Advanced Therapy Medicinal Product has received a marketing authorisation, decisions about pricing and reimbursement take place at national and regional levels. As those choices must be made in the context of the national health system of each country.
Once an Advanced Therapy Medicinal Product has been authorized for use in a country, the regulatory authorities of the country continuously monitor its safety and take action if new information indicates that the product is no longer as safe and effective as previously thought.
New promising Advanced Therapy Products are investigated every year by pharmaceutical and biotechnology companies, as well as doctors and academics, for their potential to treat diseases. The research and development process must be documented. The documents should describe the development processes including preclinical and clinical development, safety, efficacy and quality of a product. These documents are placed in the product's dossier. Many of them will be submitted to regulatory authorities.
During development of an Advanced Therapy Medicinal Product, a developer can request guidance and direction from some regulatory authorities (e.g. from EMA, FDA) on the best methods and study designs to generate robust information on how well a medicine works and how safe it is. This is known as scientific advice.
Manufacturer submits data to the regulatory authorities in countries where the company wants to sell the product. The data submitted by medicine developers in their application for marketing authorization must comply with local legislation. They must include a range of information, including on the way the Advanced Therapy Medicinal Product is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors.
Based on the assessment regulatory authorities develop an opinion whether the product can be placed on the market and used as stated by the manufacturer. In different countries the market access can be granted either by regulatory agencies responsible for pharmaceuticals and medical devices or some other governmental bodies.
Once an Advanced Therapy Medicinal Product has received a marketing authorisation, decisions about pricing and reimbursement take place at national and regional levels. As those choices must be made in the context of the national health system of each country.
Once an Advanced Therapy Medicinal Product has been authorized for use in a country, the regulatory authorities of the country continuously monitor its safety and take action if new information indicates that the product is no longer as safe and effective as previously thought.
Approval of an Advanced Therapy Medicinal Product is a complicated, lengthy and expensive process. How successful you get in doing that depends on your understanding of the approval process and quality of your product dossier.
We will put your Advanced Therapy Medicinal Product on your strategic markets in a timely and cost-efficient manner. Entrust your regulatory affairs to the professionals.
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