The hottest SFDA issued new regulations and change

On March 15, SFDA issued the newly revised regulations on the administration of drug instructions and labels (hereinafter referred to as the regulations), and issued the notice on further standardizing the administration of drug names (hereinafter referred to as the circular). Efforts should be made to solve the problem of "more than one drug" that disturbs the market order and infringes upon the legitimate rights and interests of consumers, emphasizing that the generic name of drugs must be prominent, and the use of trade names and trademarks should be strictly limited

the regulation requires that the area of the commodity list on the drug package shall not be greater than 1/2 of the common name. The position, font and background color of the general name are also strictly and specifically stipulated. It is stipulated that the horizontal label must be within the upper 1/3 range, and the vertical label must be within the right 1/3 range, with the general name prominently marked. The font is black or white, so as to form a strong contrast with the corresponding light or dark background

if a drug label uses a registered trademark, it should be printed and approved by the majority of users. If there are words in the corners of the label, the font size should not be greater than 1/4 of the general name in terms of single word area. The regulation specifically requires that unregistered trademarks and drug names not approved by SFDA shall not be used in drug instructions and labels

the regulation requires that the drug instructions should contain important scientific data, conclusions and information about the safety and effectiveness of drugs to guide consumers to use drugs safely and reasonably. The drug instructions shall fully contain the information of adverse drug reactions, and specify the adverse drug reactions in detail. If a drug manufacturing enterprise fails to modify the instructions in a timely manner according to the safety and effectiveness of the drugs after listing, or fails to fully explain the adverse reactions of drugs in the instructions, resulting in adverse consequences, the drug manufacturing enterprise shall bear the consequences

the regulation also requires that the minimum packaging produced by drug manufacturing enterprises for marketing must also be accompanied by instructions. Drug manufacturing enterprises may take the initiative to put warnings on the instructions or labels of drugs. According to the needs of protecting public health and guiding rational drug use, the food and drug administration may also require drug manufacturers to mark warnings on instructions or labels

the notice requires that the scope of use of drug trade names should be in strict accordance with the provisions of the measures for the administration of drug registration. Except for drugs with new chemical structures, new active ingredients, and drugs with compound patents, other varieties should not use trade names. If the same drug produced by the manufacturer has the same ingredients but different dosage forms or specifications, it shall use the same trade name. The trade name shall not be used alone in drug advertising, nor shall the text trademark used as the trade name without approval be used. In order to further strengthen the standardized management of drug names, SFDA will organize a nationwide special rectification work in the near future

the regulations shall enter into force on June 1st, 2006, and the original regulations on the administration of drug packaging, labeling and instructions (Provisional) shall be repealed at the same time. The notice proposed that since June 1 this year, the use of the name and trademark of newly registered drugs should meet the requirements of the provisions, and SFDA will not approve applications for trade names that have been accepted but do not meet the requirements

in order to achieve a smooth transition between the old and new regulations, SFDA also announced relevant matters. It is required that for drugs that have been approved for registration since June 1st, 2006, drug manufacturers should modify the instructions and labels of drugs in accordance with the requirements of the provisions, and submit supplementary applications to SFDA or the provincial food and Drug Administration in accordance with the provisions of the measures for the administration of drug registration. For drugs that have been accepted but not yet approved, SFDA will review and release the instructions and labels in accordance with the requirements of the regulations

the announcement proposed that the instructions and labels of drugs approved for registration before June 1, 2006 and manufactured before June 1, 2007 comply with the requirements of the "removal method: when reusing this kind of effect, the mobile phone software will enable the tacit setting of copier drug packaging, labels and instructions management regulations (provisional)" and can be sold and used within the validity period of the drug Jinan assay high-strength bolt axial force torque composite intelligent detector. The instructions and labels of all drugs manufactured since June 1st, 2007 must meet the requirements of the regulations

if it is really difficult to print the general name, specification, production batch number and expiration date of the labels of individual varieties due to special circumstances such as equipment technology, the drug manufacturer shall apply to SFDA and reduce the label content after approval

information source: P start the verification based on the force measuring ring)