Regulatory Updates

Distribution date: 21 June 2004

The Food and Drug Administration (FDA) is proposing to revise its regulations on its acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We are proposing to replace the requirement that such studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The proposed rule is intended to update the standards for the acceptance of non IND foreign studies and to help ensure the quality and integrity of data obtained from such studies.

Products Covered: Pharmaceutical Clinical Studies  (HS Chapter 3004) (ICS 11.120)

Regulation Type: Regular notification

Distribution date: 21 June 2004

The Food and Drug Administration (FDA) is proposing to revise its regulations on its acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or marketing application for a drug or biological product. We are proposing to replace the requirement that such studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The proposed rule is intended to update the standards for the acceptance of non IND foreign studies and to help ensure the quality and integrity of data obtained from such studies.

Products Covered: Pharmaceutical Clinical Studies  (HS Chapter 3004) (ICS 11.120)

Regulation Type: Regular notification

Distribution date: 17 June 2004

The KFDA has proposed the following revision to the Standards and Specifications of Foods: Establishment of the maximum residue limits (MRLs) in fowl and duck meat for enrofloxacin; and Revision of analytical method for nitrofurans metaborites and bioassay method for antibiotics in fishes and crustaceans

Products Covered: Products that have enrofloxacin, nitrofurans metaborites and antibiotics

Regulation Type: Regular notification

Distribution date: 17 June 2004

The KFDA has proposed the following revision to the Standards and Specifications of Foods: Establishment of the maximum residue limits (MRLs) in fowl and duck meat for enrofloxacin; and Revision of analytical method for nitrofurans metaborites and bioassay method for antibiotics in fishes and crustaceans

Products Covered: Products that have enrofloxacin, nitrofurans metaborites and antibiotics

Regulation Type: Regular notification

Distribution date: 08 June 2004

The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 950-2533 (1990) which is a mandatory standard and replace it with TIS 950-2547(2004). The standard covers alcohol based fuel in solid, semi-solid or gel form which is suitable for cooking and warming food. Specifies requirements for general characteristics, chemical characteristics (e.g. heat value, distilled methanol content, nitrocellulose content etc.) Prescribes working properties (i.e. ignition, stability and burning time) and storage life. Includes packaging, marking and labelling, sampling and criteria for conformity, and testing.

Products Covered: Solid fuel (HS Chapter 2905, ICS:  75.160.10)

Regulation Type: Regular notification

Distribution date: 08 June 2004

The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 950-2533 (1990) which is a mandatory standard and replace it with TIS 950-2547(2004). The standard covers alcohol based fuel in solid, semi-solid or gel form which is suitable for cooking and warming food. Specifies requirements for general characteristics, chemical characteristics (e.g. heat value, distilled methanol content, nitrocellulose content etc.) Prescribes working properties (i.e. ignition, stability and burning time) and storage life. Includes packaging, marking and labelling, sampling and criteria for conformity, and testing.

Products Covered: Solid fuel (HS Chapter 2905, ICS:  75.160.10)

Regulation Type: Regular notification

Distribution date: 04 June 2004

Define las características y especificaciones de calidad que deben cumplir los aceites vegetales comestibles incluidos, conservados mediante un tratamiento adecuado y destinados al consumo humano.

Products Covered: HS tariff headings 1507, 1508, 1511, 1512, 1513.29, 1514 and 1515

Regulation Type: Regular notification

Distribution date: 04 June 2004

Define las características y especificaciones de calidad que deben cumplir los aceites vegetales comestibles incluidos, conservados mediante un tratamiento adecuado y destinados al consumo humano.

Products Covered: HS tariff headings 1507, 1508, 1511, 1512, 1513.29, 1514 and 1515

Regulation Type: Regular notification

Distribution date: 04 June 2004

Define los parámetros y especificaciones de calidad de los cementos hidráulicos y de los componentes de éstos que normalmente se usan en el territorio nacional, sean producidos localmente o importados. Así como establecer la clasificación de dichos cementos por tipos, con sus respectivas especificaciones.

Products Covered: HS tariff item No. 2523.90.00.00

Regulation Type: Regular notification

Distribution date: 04 June 2004

Define los parámetros y especificaciones de calidad de los cementos hidráulicos y de los componentes de éstos que normalmente se usan en el territorio nacional, sean producidos localmente o importados. Así como establecer la clasificación de dichos cementos por tipos, con sus respectivas especificaciones.

Products Covered: HS tariff item No. 2523.90.00.00

Regulation Type: Regular notification