The above is applicable for finished products distributed in Italy or exported elsewhere. (Equivalent to the US FDA ban) 中文概要: 意大利药监AIFA建议所有的上市许可持有人,若在其注册申报中将位于中国山东东营南仁路1236号的东营天东制药有限公司...
before causing harm,” says FDA Principal Deputy Commissioner Janet Woodcock. The existing regulatory framework for food and supplements are inappropriate for CBD, she says, and the FDA does not, in fact, intend to pursue rulemaking that would allow for the inclusion of CBD in dietary supplements...
when the European Commission (EC) first revealed details of the implementation of new EU rules for GMP standards for imported APIs, both the pharmaceutical industry and regulators warned about the potential dangers of these restrictions in causing medicines shortages. The...
Enactment in the United States of the FDA Food Safety Modernization Act (FSMA) in January 2011 adds a new element to the discussion of private standards. The Act mandates the introduction of risk‐based controls on domestic farms for fruits and vegetables deemed high risk. It also places an ...
This is a set of federal regulations to be followed by fields governed by the FDA, such as those in the life sciences industry. Title 21 Part 11 defines electronic records and electronic signatures, and further lays down the criteria by which they may be deemed trustworthy, reliable, and eq...
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections. In a landmark decision, the United States FDA and the European Commission announced on March 2, 2017 that they will recognize each other’s inspection...
2.12.It follows that, in laying down the GMP requirements applicable to ATMPs, it is necessary to recognise a certain level of flexibility so that the ATMP manufacturer can implement the measures that are most appropriate having regard to specific characteristics of the manufacturing process and of...
In 1999, the Food and Drug Administration (FDA) issued a warning to physicians about the safety of intravenous immunoglobulins (IVIG) products. In this document, the FDA also provided advice regarding proper patient management surrounding the administration of IVIG. For sucrose-containing IVIGs, FDA...
此类产品在FDA相关法规中类似的命名是HCT/P(HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS),相关的法规主要是21 CFR Part 1271,以及42 U.S.C的有关章节。42 U.S.C中有原PHS Act Section 351和361的内容(对应42 U.S.C Section 262和264),即业界俗称的“351产品”和“361产品”。21 CF...
Like the EU MDR, the IVDR lumps devices into 4 regulatory groups, with low-risk Class A IVDs equivalent to the MDR's Class I medical devices and so on. Class A IVDs can be self-certified, while all other device classes require assessment and approval by an EU Notified Body. ...