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1.

Heightened Oversight Mandated for Shenzhen Pharmaceutical Suppliers

18 April 2018

Pharmaceutical suppliers active in and around Shenzhen are facing heightened supervision to ensure compliance with the Good Supply Practices for Pharmaceutical Products (GSP)....Read More

2.

Triggering of EU Law Imminent to Further Restrict Allergy-causing Substance “MI” in Cosmetic Products

6 April 2018

As from 27 April 2018, only cosmetic products which comply with a particular Regulation dating from 2017 may be made available by sellers on the European Union market. The law concerned is Regulation ...Read More

3.

Microplastic Particles in Products: ECHA Calls for Evidence Concerning Intentional Uses

23 March 2018

Upon request of the European Commission, the European Chemicals Agency (ECHA) is currently conducting an investigation into microplastic particles (also known as microbeads) intentionally added to or ...Read More

4.

Upgraded Requirements Introduced for Dietary Supplement Labelling

16 March 2018

New labelling requirements with regard to dietary supplements were introduced by the China Food and Drug Administration (CFDA) on 14 February this year and came into immediate effect....Read More

5.

Sweden to Ban Microplastics in Some Cosmetics Products

9 March 2018

On 1 February 2018, the Swedish government announced plans to ban the sale of rinse-off cosmetic products containing microplastics from July this year, to help reduce plastic marine litter. The ban, d...Read More

6.

Imports of All Remaining Fentanyl-Related Substances Restricted, Controls on Synthetic Cannabinoid Extended

15 Feb 2018

The U.S. Department of Justice reports that a manufacturer and exporter of wind turbines based in mainland China has been convicted of conspiracy to commit trade secret theft, theft of trade secrets a...Read More

7.

Substances Known As D4 And D5 Become Subject to EU-wide Restriction in “Wash-off” Cosmetic Products

9 Feb 2018

On 11 January 2018, Regulation 2018/35 restricting the substances octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’) was published in the Official Journal. The substances are ...Read More

8.

Taiwan Prohibits the Use of Safrole and 14 Other Substances in Cosmetics

19 Jan 2018

The Food and Drug Administration in Taiwan (TFDA) published notice No. 1061608566 on December 8, 2017, banning the importation, manufacture, sale and distribution of cosmetics containing Safrole and 1...Read More

9.

DEA to Restrict Imports of All Remaining Fentanyl-Related Substances

19 Jan 2018

The Drug Enforcement Administration has announced its intent to issue an order adding to schedule I of the Controlled Substances Act all fentanyl-related substances that are not currently listed in an...Read More

10.

Import Restrictions Imposed on Opioid Analgesic Drug

5 Jan 2018

The Drug Enforcement Administration has issued a final order that temporarily schedules the opioid MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), including its salts, isomers and salts of isome...Read More

11.

CFDA Issues New Rules on Medical Device Clinical Trial Institutions

28 Dec 2017

The Administrative Provisions on the Qualifications and Record Filing of Clinical Trial Institutions for Medical Devices jointly issued by the China Food and Drug Administration (CFDA) and the Nationa...Read More

12.

FDA Issues Guidance on Gluten Labelling of Certain Drug Products

22 Dec 2017

The FDA has issued a draft guidance document on gluten in drug products and associated labelling recommendations....Read More

13.

New Procedures Announced for Accreditation of TCM Practitioners

20 Dec 2017

As of 20 December this year, any individual who has studied Traditional Chinese Medicine (TCM) under a master/apprentice scheme – or has accumulated considerable skills in the sector following a numbe...Read More

14.

European Commission Restricts the Use of Peanut Oil and Hydrolysed Wheat Protein in Cosmetics

15 Dec 2017

Hong Kong’s exporters to the EU of cosmetic products should be alerted to a legislative development that may affect them. On 5 December 2017, Regulation 2017/2228 was published which restricts the use...Read More

15.

Canada Amends Radiation Regulations for Dental Equipment

8 Dec 2017

The Canadian government has amended the current radiation regulations for X-ray dental equipment effective 15 May 2018 in an effort to strengthen radiation safety requirements - in alignment with Inte...Read More

16.

Chile Extends Deadline to Comply with Restrictions on Antibacterial Agents in Cosmetic Products

8 Dec 2017

Chilean authorities have delayed until 12 October 2018 the entry into force of certain restrictions on the use of antibacterial agents in rinse-off cosmetic products....Read More

17.

Online Pharmaceutical and Medical Device Sales Brought in Line with Offline Regulatory Regime

5 Dec 2017

In line with the principle that online and offline transactions should be subject to identical regulatory regimes, the online trade in pharmaceuticals and medical devices is to face the same level of ...Read More

18.

INDIA: Suppliers of Medical Devices and Pharmaceuticals Face Liability for Any Harm to Users

27 Nov 2017

Pharmaceutical companies and medical device manufacturers in India may soon be liable to pay compensation should the use of their products cause harm to any user....Read More

19.

New Guidelines for Evaluating Consistent Quality and Efficacy of Generic Drugs

27 Oct 2017

The China Food and Drug Administration (CFDA) has issued guidelines relating to the evaluation of consistent quality and efficacy of generic drugs. The guidelines apply to domestically-produced and im...Read More

20.

Andean Community Prohibits Anti-bacterial Soaps

27 Oct 2017

The Andean Community, which includes Bolivia, Colombia, Ecuador and Peru, recently adopted a regulation banning the use of anti-bacterial and anti-microbial agents in cosmetic and personal hygiene soa...Read More

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