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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


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


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


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


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


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


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The FDA has issued a draft guidance document on gluten in drug products and associated labelling recommendations....Read More


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


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


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


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


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


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


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


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


INDONESIA: One-Stop Online Halal Certification Service Set for 2018 Launch

17 Oct 2017

Online halal certification will be on offer to producers of foodstuffs, pharmaceuticals and cosmetics following the early 2018 launch of a one-stop government-backed service portal....Read More


Inspection and Quarantine Required for Entry and Exit of Perfume and Floral Water

4 Oct 2017

Perfume and floral water are now subject to inspection by the entry-exit inspection and quarantine authorities....Read More


Shanghai Specifies Priority Approval Requirements for Class II Medical Devices

18 Sept 2017

New priority approval procedures for Class II medical devices – those whose use is deemed to require a degree of professional supervision – have been adopted in the Shanghai municipal area. Details of...Read More


Substantial Increase in Registration Fee for Medical Device Facilities

15 Sept 2017

The Food and Drug Administration has increased the fee for medical device facility registrations by 37 percent for fiscal year 2018....Read More


EU Adopts New Regulations on Cosmetics Aimed at Restricting Use of Fragrance Allergens and a Colorant

8 Sept 2017

On 3 and 4 August 2017, the European Commission published two new regulations, Commission Regulation 2017/1410 and Commission Regulation 2017/1413. Both are aimed at revising Regulation 1223/2009, whi...Read More

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