Regulatory Updates

Distribution date: 14 July 2022 | Final date for Comment: 09 September 2022

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University, proposing that the food additive regulations be amended to remove or restrict authorizations for the use of bisphenol A (BPA). 

Products Covered: Phenols; phenol-alcohols (HS code(s): 2907); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This normative instruction contains provisions on the production of pilot batches of medicines.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This normative instruction contains provisions on the production of pilot batches of medicines.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This Resolution contains provisions on marketing authorization, renewal of marketing authorization, post-marketing authorization changes and notification of industrialized dynamized drugs.   The current editions of the following pharmacopoeias and compendia should be used as a reference for production methods and quality control of drugs, excipients, active ingredients and industrialized dynamized drugs: I - Brazilian Homeopathic Pharmacopoeia; II - German Homeopathic Pharmacopoeia (GHP/HAB); III - American Homeopathic Pharmacopoeia (HPUS); IV - British Homeopathic Pharmacopoeia (BHP); V - Mexican Homeopathic Pharmacopoeia; VI - Indian Homeopathic Pharmacopoeia; VII - European Pharmacopoeia (Ph. EUR.); VIII - French Pharmacopoeia (PhFr); or IX - Anthroposophical Pharmaceutical Code (APC).

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 13 July 2022

This Resolution contains provisions on marketing authorization, renewal of marketing authorization, post-marketing authorization changes and notification of industrialized dynamized drugs.   The current editions of the following pharmacopoeias and compendia should be used as a reference for production methods and quality control of drugs, excipients, active ingredients and industrialized dynamized drugs: I - Brazilian Homeopathic Pharmacopoeia; II - German Homeopathic Pharmacopoeia (GHP/HAB); III - American Homeopathic Pharmacopoeia (HPUS); IV - British Homeopathic Pharmacopoeia (BHP); V - Mexican Homeopathic Pharmacopoeia; VI - Indian Homeopathic Pharmacopoeia; VII - European Pharmacopoeia (Ph. EUR.); VIII - French Pharmacopoeia (PhFr); or IX - Anthroposophical Pharmaceutical Code (APC).

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 12 July 2022

This Resolution contains provisions on post-approval changes of herbal medicines and traditional herbal products.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 12 July 2022

This Resolution contains provisions on post-approval changes of herbal medicines and traditional herbal products.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 12 July 2022

This Resolution contains provisions on products for amateur gardening and their marketing authorization.  

Products Covered: ENVIRONMENT. HEALTH PROTECTION. SAFETY (ICS code(s): 13) - Gardening products

Regulation Type: Regular notification

Distribution date: 12 July 2022

This Resolution contains provisions on products for amateur gardening and their marketing authorization.  

Products Covered: ENVIRONMENT. HEALTH PROTECTION. SAFETY (ICS code(s): 13) - Gardening products

Regulation Type: Regular notification

Distribution date: 12 July 2022 | Final date for Comment: 11 August 2022

The Minimum Requirements for Biological Products will be amended as follows；To add the standard, criterion, fee and quantity for a vaccine product to be newly approved; “Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine”, “Pneumococcal 15-valent conjugate vaccine”. Partially amended to “Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine”, “Pneumococcal Vaccine Polyvalent”, “Pneumococcal 13-valent conjugate vaccine”, “Smallpox Vaccine Prepared in Cell Culture”, “Freeze-dried Smallpox Vaccine Prepared in Cell Culture”. To delete “Pneumococcal 10-valent conjugate vaccine”, “Smallpox Vaccine”, “Freeze-dried Smallpox Vaccine”.The Public Notice on National Release Testing will be amended as follows； To add the criterion, fee and quantity for a vaccine product to be newly approved; “Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine”, “Pneumococcal 15-valent conjugate vaccine”. Partially amended to “Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine”, “Pneumococcal Vaccine Polyvalent”, “Pneumococcal 13-valent conjugate vaccine”, “Smallpox Vaccine Prepared in Cell Culture”, “Freeze-dried Smallpox Vaccine Prepared in Cell Culture”. To delete “Pneumococcal 10-valent conjugate vaccine”, “Smallpox Vaccine”, “Freeze-dried Smallpox Vaccine”.

Products Covered: Pharmaceutical products (HS code(s): 30)

Regulation Type: Regular notification